{"id":40,"date":"2022-11-01T12:46:47","date_gmt":"2022-11-01T12:46:47","guid":{"rendered":"https:\/\/operonstrategist.com\/costarica\/?page_id=40"},"modified":"2025-12-27T09:45:45","modified_gmt":"2025-12-27T09:45:45","slug":"fda-510-k","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-de\/services\/regulatory-approvals\/fda-510-k\/","title":{"rendered":"FDA 510 (K)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"40\" class=\"elementor elementor-40\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5adfc496 banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5adfc496\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7081858c\" data-id=\"7081858c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-23608792 banner-sec-heading elementor-widget elementor-widget-heading\" data-id=\"23608792\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">FDA 510(K) Submission &amp; Certification in Germany.<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3eb1042d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3eb1042d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-42d000f4\" data-id=\"42d000f4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6cee077e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6cee077e\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-6bf44d61\" data-id=\"6bf44d61\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d9ed41d elementor-widget elementor-widget-heading\" data-id=\"d9ed41d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is FDA 510(k) Certification?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d762c4e elementor-widget elementor-widget-text-editor\" data-id=\"5d762c4e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>FDA 510(k) is a regulatory process mandated by the US Food and Drug Administration (FDA) to ensure that medical devices marketed in the United States are safe, effective, and legally compliant. The submission involves proving that a device is substantially equivalent to an existing legally marketed device (predicate device).<\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\">Class I Devices: Generally exempt from 510(k) requirements.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Class II Devices: Require 510(k) submission for clearance.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Class III Devices: High-risk devices need premarket approval (PMA).<\/li><\/ul><p>Achieving FDA 510(k) clearance allows manufacturers to legally market their medical devices in the USA. For German manufacturers seeking access to the US market, compliance with these regulations is crucial.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f96602c elementor-widget elementor-widget-heading\" data-id=\"3f96602c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How to Register Medical Device in US FDA?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d1b6884 elementor-widget elementor-widget-text-editor\" data-id=\"d1b6884\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>To register your medical device with the FDA:<\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\">Determine the Classification: Identify if your device is Class I, II, or III based on associated risks.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">510(k) Submission: Required for Class II devices.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">PMA Submission: Mandatory for Class III devices.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Compliance with QSR: Adhere to <a href=\"https:\/\/operonstrategist.com\/en-de\/services\/turnkey-project-consultants\/fda-21-cfr-part-820-quality-system-regulation\/\">21 CFR Part 820 Quality System Regulations.<\/a><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-4d80426 animated-slow elementor-invisible\" data-id=\"4d80426\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInUp&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7c8e757 elementor-widget elementor-widget-heading\" data-id=\"7c8e757\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Let's Grow Your Business Together<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-744ace8 elementor-widget elementor-widget-text-editor\" data-id=\"744ace8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Fill the Form or Mail Us to:\u00a0<a href=\"mailto:enquiry@operonstrategist.com\">enquiry@operonstrategist.com<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe69c3e elementor-widget elementor-widget-wpforms\" data-id=\"fe69c3e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-2624\"><form id=\"wpforms-form-2624\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"2624\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/en-de\/wp-json\/wp\/v2\/pages\/40\" data-token=\"b34a8aedc44d3cc2213da2a7ebafb449\" data-token-time=\"1775383021\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-2624-field_0-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"0\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2624-field_0\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-2624-field_0\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][0]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-2624-field_0-error\" required><\/div><div id=\"wpforms-2624-field_1-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-2624-field_1\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-2624-field_1\" class=\"wpforms-field-large wpforms-field-required\" 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Marketing<\/option><option value=\"Referred by colleague\"  class=\"choice-4 depth-1\"  >Referred by colleague<\/option><option value=\"Shows\/Exhibition\"  class=\"choice-5 depth-1\"  >Shows\/Exhibition<\/option><option value=\"Print Advertisement\"  class=\"choice-6 depth-1\"  >Print Advertisement<\/option><option value=\"Other\"  class=\"choice-7 depth-1\"  >Other<\/option><\/select><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"2624\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/pages\/40\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-2624\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/en-de\/wp-content\/plugins\/wpforms-lite\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-74566553 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"74566553\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-275dcf23\" data-id=\"275dcf23\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ba00e4f elementor-widget elementor-widget-text-editor\" data-id=\"ba00e4f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5><b>Classification Overview<\/b><span style=\"font-weight: 400;\">:<\/span><\/h5><table><tbody><tr><td><p><b>Class<\/b><\/p><\/td><td><p><b>Risk Level<\/b><\/p><\/td><td><p><b>Examples<\/b><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Class I<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Low Risk<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Bandages, hospital furniture<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Class II<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Moderate Risk<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Catheters, surgical gloves<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Class III<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">High Risk<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Pacemakers, defibrillators<\/span><\/p><\/td><\/tr><\/tbody><\/table><p><span style=\"font-weight: 400;\">Understanding the correct classification is key to determining whether your device requires FDA 510(k) clearance or PMA submission.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a9a1090\" data-id=\"a9a1090\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bc577df elementor-widget elementor-widget-image\" data-id=\"bc577df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1200\" height=\"628\" src=\"https:\/\/operonstrategist.com\/en-de\/wp-content\/uploads\/2022\/11\/US-FDA-510K-CLEARANCE-PREMARKET-APPROVAL.jpg\" class=\"attachment-full size-full wp-image-329\" alt=\"fda 510(k)\" srcset=\"https:\/\/operonstrategist.com\/en-de\/wp-content\/uploads\/2022\/11\/US-FDA-510K-CLEARANCE-PREMARKET-APPROVAL.jpg 1200w, https:\/\/operonstrategist.com\/en-de\/wp-content\/uploads\/2022\/11\/US-FDA-510K-CLEARANCE-PREMARKET-APPROVAL-300x157.jpg 300w, https:\/\/operonstrategist.com\/en-de\/wp-content\/uploads\/2022\/11\/US-FDA-510K-CLEARANCE-PREMARKET-APPROVAL-1024x536.jpg 1024w, https:\/\/operonstrategist.com\/en-de\/wp-content\/uploads\/2022\/11\/US-FDA-510K-CLEARANCE-PREMARKET-APPROVAL-768x402.jpg 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7ea6a57b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7ea6a57b\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-44bbb664\" data-id=\"44bbb664\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c8e3b8a elementor-widget elementor-widget-text-editor\" data-id=\"c8e3b8a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><strong>Medical Device Classification For US FDA Registration:<\/strong><\/h2>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-431c80d4 elementor-widget elementor-widget-text-editor\" data-id=\"431c80d4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr; font-family: 'Segoe UI', 'Segoe UI Web', Arial, Verdana, sans-serif; font-size: 12px; background-color: #ffffff;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\">\u00a0<\/p><\/div><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr; font-family: 'Segoe UI', 'Segoe UI Web', Arial, Verdana, sans-serif; font-size: 12px; background-color: #ffffff;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-variant-numeric: normal; font-variant-east-asian: normal; font-size: 12pt; line-height: 20.5042px; font-family: georgia, palatino;\" xml:lang=\"EN-US\" data-contrast=\"none\">FDA 510(k) medical device classification depend on the intended use of the device. The devices are classified as Class 1, Class 2, and Class 3 medical devices as per the risk associated with them.<\/span><\/p><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-variant-numeric: normal; font-variant-east-asian: normal; font-size: 12pt; line-height: 20.5042px; font-family: georgia, palatino;\" xml:lang=\"EN-US\" data-contrast=\"none\">\u00a0<\/span><\/p><\/div><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr; font-family: 'Segoe UI', 'Segoe UI Web', Arial, Verdana, sans-serif; font-size: 12px; background-color: #ffffff;\"><div class=\"TableContainer Ltr SCXW59562759 BCX0\" style=\"margin: 2px 0px 2px -5px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; position: relative; display: flex; justify-content: flex-start;\"><div id=\"{625dda3c-028a-4032-90e7-a8cee32747b3}{54}\" class=\"WACAltTextDescribedBy SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; visibility: hidden; z-index: -100;\" aria-hidden=\"true\">\u00a0<\/div><table class=\"Table TableStaticStyles Ltr TableWordWrap SCXW59562759 BCX0\" style=\"margin-bottom: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; table-layout: fixed; width: 0px; overflow: visible; border-collapse: collapse; empty-cells: show; position: relative; background: transparent;\" border=\"1\" data-tablestyle=\"MsoTableGrid\" data-tablelook=\"1696\" aria-rowcount=\"4\"><tbody class=\"SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent;\"><tr class=\"TableRow SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; height: 0px;\" role=\"row\" aria-rowindex=\"1\"><td class=\"FirstRow FirstCol SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" role=\"rowheader\" data-celllook=\"0\"><div class=\"TableHoverRowHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; display: flex; overflow: visible; width: 15px; height: 10px; cursor: pointer; z-index: 5; background-color: transparent; bottom: -5.5px; left: -15.5px;\">\u00a0<\/div><div class=\"TableHoverColumnHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; width: 20px; height: 12px; top: -12.5px; left: auto; cursor: pointer; z-index: 4; text-align: center; display: inline-block; background-color: transparent; right: -10.5px;\">\u00a0<\/div><div class=\"TableCellLeftBorderHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; width: 7px; z-index: 3; background-repeat: repeat; cursor: pointer; height: 20.5px; left: -4px;\">\u00a0<\/div><div class=\"TableCellTopBorderHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; cursor: pointer; left: 0px; width: 207px; top: -4px;\">\u00a0<\/div><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Class<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><td class=\"FirstRow SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" role=\"columnheader\" data-celllook=\"0\"><div class=\"TableHoverColumnHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; width: 20px; height: 12px; top: -12.5px; left: auto; cursor: pointer; z-index: 4; text-align: center; display: inline-block; background-color: transparent; right: -10.5px;\">\u00a0<\/div><div class=\"TableCellTopBorderHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; cursor: pointer; left: 0px; width: 207px; top: -4px;\">\u00a0<\/div><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Type of Risk<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><td class=\"FirstRow LastCol SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" role=\"columnheader\" data-celllook=\"0\"><div class=\"TableHoverColumnHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; width: 20px; height: 12px; top: -12.5px; left: auto; cursor: pointer; z-index: 4; text-align: center; display: inline-block; background-color: transparent; right: -10.5px;\">\u00a0<\/div><div class=\"TableCellTopBorderHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; cursor: pointer; left: 0px; width: 207px; top: -4px;\">\u00a0<\/div><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Examples\u00a0<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><\/tr><tr class=\"TableRow SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; height: 0px;\" role=\"row\" aria-rowindex=\"2\"><td class=\"FirstCol SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" role=\"rowheader\" data-celllook=\"0\"><div class=\"TableHoverRowHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; display: flex; overflow: visible; width: 15px; height: 10px; cursor: pointer; z-index: 5; background-color: transparent; bottom: -5.5px; left: -15.5px;\">\u00a0<\/div><div class=\"TableCellLeftBorderHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; width: 7px; z-index: 3; background-repeat: repeat; cursor: pointer; height: 20.5px; left: -4px;\">\u00a0<\/div><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Class 1<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><td class=\"SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" data-celllook=\"0\"><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Low risk (General control)<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><td class=\"LastCol SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" data-celllook=\"0\"><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Hospital furniture, Bandages\u00a0<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><\/tr><tr class=\"TableRow SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; height: 0px;\" role=\"row\" aria-rowindex=\"3\"><td class=\"FirstCol SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" role=\"rowheader\" data-celllook=\"0\"><div class=\"TableHoverRowHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; display: flex; overflow: visible; width: 15px; height: 10px; cursor: pointer; z-index: 5; background-color: transparent; bottom: -5.5px; left: -15.5px;\">\u00a0<\/div><div class=\"TableCellLeftBorderHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; width: 7px; z-index: 3; background-repeat: repeat; cursor: pointer; height: 20.5px; left: -4px;\">\u00a0<\/div><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Class 2<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><td class=\"SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" data-celllook=\"0\"><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Moderate risk\u00a0<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><td class=\"LastCol SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" data-celllook=\"0\"><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Catheters, surgical gloves\u00a0<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><\/tr><tr class=\"TableRow SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; height: 0px;\" role=\"row\" aria-rowindex=\"4\"><td class=\"FirstCol LastRow SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" role=\"rowheader\" data-celllook=\"0\"><div class=\"TableHoverRowHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; display: flex; overflow: visible; width: 15px; height: 10px; cursor: pointer; z-index: 5; background-color: transparent; bottom: -5.5px; left: -15.5px;\">\u00a0<\/div><div class=\"TableCellLeftBorderHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; width: 7px; z-index: 3; background-repeat: repeat; cursor: pointer; height: 20.5px; left: -4px;\">\u00a0<\/div><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Class 3<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><td class=\"LastRow SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" data-celllook=\"0\"><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">High risk<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><td class=\"LastCol LastRow SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; vertical-align: top; overflow: visible; position: relative; background-color: transparent; border-top: 1px solid #000000; border-left: 1px solid #000000; border-right-style: solid; border-bottom-style: solid; border-right-color: #000000; border-bottom-color: #000000; border-image: initial; width: 207px;\" data-celllook=\"0\"><div class=\"TableColumnResizeHandle SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; bottom: 0px; overflow: visible; width: 7px; top: -0.5px; z-index: 3; background-repeat: repeat; height: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/hD55E5E9C2AD2E4F5_resources\/1033\/ColResize.cur'), pointer; right: -4px;\">\u00a0<\/div><div class=\"TableInsertRowGapBlank SCXW59562759 BCX0\" style=\"margin: -3px 0px 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; position: absolute; overflow: visible; height: 7px; z-index: 3; background-repeat: repeat; background-color: transparent; left: -0.5px; width: calc(100% + 1px); cursor: url('https:\/\/c1h-word-edit-15.cdn.office.net:443\/we\/s\/h1E5273DBAA04AEF6_resources\/1033\/RowResize.cur'), pointer; bottom: -4px;\">\u00a0<\/div><div class=\"TableCellContent SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px 7px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible;\"><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\" data-contrast=\"auto\">Pacemakers, defibrillators<\/span><span class=\"EOP SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-size: 12pt; line-height: 20.5042px;\" data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559740&quot;:259}\">\u00a0<\/span><\/span><\/p><\/div><\/div><\/td><\/tr><\/tbody><\/table><\/div><\/div><div class=\"OutlineElement Ltr SCXW59562759 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow: visible; cursor: text; clear: both; position: relative; direction: ltr; font-family: 'Segoe UI', 'Segoe UI Web', Arial, Verdana, sans-serif; font-size: 12px; background-color: #ffffff;\"><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-variant-numeric: normal; font-variant-east-asian: normal; font-size: 12pt; line-height: 20.5042px; font-family: georgia, palatino;\" xml:lang=\"EN-US\" data-contrast=\"none\">\u00a0<\/span><\/p><p class=\"Paragraph SCXW59562759 BCX0\" style=\"margin-bottom: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; overflow-wrap: break-word; white-space: pre-wrap; font-weight: normal; font-style: normal; font-kerning: none; background-color: transparent; color: windowtext; text-align: justify;\"><span style=\"font-family: georgia, palatino;\"><span class=\"TextRun SCXW59562759 BCX0\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; font-variant-numeric: normal; font-variant-east-asian: normal; font-size: 12pt; line-height: 20.5042px;\" xml:lang=\"EN-US\" data-contrast=\"none\">The medical device classification can be confusing for manufacturers as they have limited exposure to the system. Class 1 devices are subjected to fewer regulatory requirements as compared to class 2 and class 3 devices. For the regulatory compliance of your medical device, you should know the class of your device, so that you can apply for FDA 510(k) clearance or PMA process.<\/span><\/span><\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34d5d21 elementor-widget elementor-widget-heading\" data-id=\"34d5d21\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why FDA 510(k) Matters for German Manufacturers\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f6718b8 elementor-widget elementor-widget-text-editor\" data-id=\"f6718b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>For German medical device manufacturers, entering the US market presents significant opportunities. FDA 510(k) clearance ensures:<\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\">Global Market Access: Gain a foothold in one of the largest medical device markets.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Regulatory Compliance: Meet stringent US safety and efficacy standards.<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Enhanced Credibility: Strengthen your brand reputation internationally.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-75be69b9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"75be69b9\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-3f6c68e5\" data-id=\"3f6c68e5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1f27db7f elementor-widget elementor-widget-heading\" data-id=\"1f27db7f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How Can Operon Strategist's Help in US FDA 510(k) Registration?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66f5d290 elementor-widget elementor-widget-text-editor\" data-id=\"66f5d290\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Operon Strategist<span style=\"font-weight: 400;\"> offers end-to-end consulting services for German manufacturers navigating the complex FDA 510(k) submission process.<\/span><\/p><h4>Our Services Include:<\/h4><ol><li style=\"font-weight: 400;\" aria-level=\"1\">Predicate Device Identification<span style=\"font-weight: 400;\">: Help in finding existing legally marketed devices for comparison.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Substantial Equivalence Evaluation<span style=\"font-weight: 400;\">: Analyze and document equivalence between your device and predicate devices.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Technical File Preparation<span style=\"font-weight: 400;\">: Create a comprehensive 510(k) submission with all required data.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/en-de\/services\/\">Regulatory Guidance<\/a><span style=\"font-weight: 400;\">: Assist in responding to FDA queries and additional information requests.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/en-de\/services\/turnkey-project-consultants\/quality-management-system\/\">QMS Compliance<\/a> Support<span style=\"font-weight: 400;\">: Align your processes with <\/span>21 CFR Part 820<span style=\"font-weight: 400;\"> Quality System Regulations.<\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">With years of experience, our team collaborates closely with notified bodies and stays updated on FDA regulatory requirements.<\/span><\/p><p><span style=\"font-weight: 400; font-family: georgia, palatino;\">To discuss your support needs you can <a href=\"mailto:enquiry@operonstartegist.com\">mail us at\u00a0 enquiry@operonstartegist.com<\/a> <\/span><span style=\"font-weight: 400; font-family: georgia, palatino;\">or you can <a href=\"https:\/\/api.whatsapp.com\/send?phone=919370283428&amp;text=I%20am%20looking%20for%20CDSCO,%20CE,%20SFDA,%20FDA,%20UKCA%20or%20Manufacturing%20plant%20setup.\" target=\"_blank\" rel=\"noopener\">WhatsApp<\/a> us your queries, and we answer them shortly.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1d2c6dc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1d2c6dc\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c7213e6\" data-id=\"c7213e6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7671005 elementor-widget elementor-widget-heading\" data-id=\"7671005\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQ'S<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-303ee64 elementor-widget elementor-widget-accordion\" data-id=\"303ee64\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5051\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-5051\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Do all medical devices require a 510k?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5051\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-5051\"><p>Most medical devices marketed in the United States do not require the completion of a 510(k) submission. Determining if your device is 510(k) exempt or not is a crucial first step.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5052\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-5052\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What are the three types of 510k?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5052\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-5052\"><p>There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different devices.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5053\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-5053\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Does a 510k expire?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5053\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-5053\"><p>No. After FDA grants clearance, the device is issued a 510(k) registration number. This number never expires and remains tied to the device.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5054\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-5054\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">How long does the FDA 510k process take?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5054\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-5054\"><p>The FDA 510(k) review process typically takes about 90 days. However, the timeline may be longer depending on the completeness of the submission and whether FDA requests additional information.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-5055\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-5055\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">What is the difference between FDA approval and 510k clearance?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-5055\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-5055\"><p>FDA approval is required for high-risk Class III devices, while 510(k) clearance applies to most Class II and some Class I devices. Clearance means the device is substantially equivalent to an existing legally marketed device.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9c86d92 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9c86d92\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-169ffb4\" data-id=\"169ffb4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4037739 elementor-widget elementor-widget-heading\" data-id=\"4037739\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">US FDA 510k Consultancy Services Worldwide<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-13a0414 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"13a0414\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-03c1317\" data-id=\"03c1317\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-743340c elementor-widget elementor-widget-text-editor\" data-id=\"743340c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong><a href=\"https:\/\/operonstrategist.com\/en-sa\/services\/regulatory-approvals\/fda-510k\/\">Saudi Arabia\u00a0<\/a><\/strong><\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/regulatory-approvals\/fda-510k\/\">Egypt<\/a><\/strong><\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/en-ir\/fda-510-k\/\">Iran<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-8d98f9f\" data-id=\"8d98f9f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6ea4e32 elementor-widget elementor-widget-text-editor\" data-id=\"6ea4e32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong><a href=\"https:\/\/operonstrategist.com\/en-gb\/services\/regulatory-approvals\/fda-510-k\/\">UK<\/a><\/strong><\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/en-de\/services\/regulatory-approvals\/fda-510-k\/\">Germany<\/a><\/strong>\u00a0<\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/en-cr\/services\/regulatory-approvals\/fda-510-k\/\">Costa Rica<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-322e75a\" data-id=\"322e75a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d523ff1 elementor-widget elementor-widget-text-editor\" data-id=\"d523ff1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong><a href=\"https:\/\/operonstrategist.com\/en-nl\/services\/regulatory-approvals\/fda-510-k\/\">Netherlands<\/a><\/strong><\/p><p><strong><a href=\"https:\/\/operonstrategist.com\/en-om\/services\/regulatory-approvals\/fda-510-k\/\">Oman<\/a><\/strong><\/p><p><strong><a href=\"https:\/\/us.operonstrategist.com\/services\/fda-510k-consultant-for-usa\/\">USA<\/a><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-5ae65f7\" data-id=\"5ae65f7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f8396ae elementor-widget elementor-widget-text-editor\" data-id=\"f8396ae\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong><a href=\"https:\/\/operonstrategist.com\/en-za\/services\/regulatory-approvals\/fda-510-k\/\">South Africa<\/a><\/strong><\/p><p><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/fda-510k\/\"><strong>India<\/strong><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FDA 510(K) Submission &amp; Certification in Germany. What is FDA 510(k) Certification? FDA 510(k) is a regulatory process mandated by the US Food and Drug Administration (FDA) to ensure that medical devices marketed in the United States are safe, effective, and legally compliant. The submission involves proving that a device is substantially equivalent to an [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":329,"parent":20,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-40","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/pages\/40","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/comments?post=40"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/pages\/40\/revisions"}],"predecessor-version":[{"id":4437,"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/pages\/40\/revisions\/4437"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/pages\/20"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/media\/329"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-de\/wp-json\/wp\/v2\/media?parent=40"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}