{"product_id":"fda-510k-k170826","title":"FDA 510(k) K170826, Perfadex Plus, by Xvivo Perfusion AB","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eSystem, Perfusion, Kidney\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK170826\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Perfadex Plus\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Xvivo Perfusion AB\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.588\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eKDN\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2017-03-20\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2018-06-22\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eGastroenterology\/Urology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 2,271\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,818\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 453\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309544898724,"sku":"FDA510K170826","price":1197.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k170826","provider":"FOIA Document Source","version":"1.0","type":"link"}