{"product_id":"fda-510k-k183309","title":"FDA 510(k) K183309, stentfix OTSC System Set, by Ovesco Endoscopy AG","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eHemostatic Metal Clip For The Gi Tract\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK183309\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e stentfix OTSC System Set\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Ovesco Endoscopy AG\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.44\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003ePKL\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2018-11-29\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2019-10-22\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 1,822\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,175\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 647\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51315379503268,"sku":"FDA510K183309","price":1591.21,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k183309","provider":"FOIA Document Source","version":"1.0","type":"link"}