{"product_id":"fda-510k-k173796-parietex-surgical-mesh-composite-mesh-and-optimized-composite-mesh","title":"FDA 510(k) K173796, Parietex Surgical Mesh, Composite Mesh and Optimized Composite Mesh, by Sofradim Production","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K173796 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Sofradim Production\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Mesh, Surgical, Polymeric \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e FTL \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 12\/14\/2017 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/09\/2018 \u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE) \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery\u003c\/p\u003e\n\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003e\u003cstrong data-start=\"57\" data-end=\"73\"\u003eTotal pages:\u003c\/strong\u003e 1,433\u003cbr data-start=\"79\" data-end=\"82\"\u003e\u003cstrong data-start=\"82\" data-end=\"107\"\u003eFully redacted pages:\u003c\/strong\u003e 1,166\u003cbr data-start=\"113\" data-end=\"116\"\u003e\u003cstrong data-start=\"116\" data-end=\"134\"\u003eContent pages:\u003c\/strong\u003e 267\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429476958372,"sku":"FDA510K173796","price":631.44,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k173796-parietex-surgical-mesh-composite-mesh-and-optimized-composite-mesh","provider":"FOIA Document Source","version":"1.0","type":"link"}