{"product_id":"fda-510k-k241168","title":"FDA 510(k) K241168, System 83 Revolve Endoscope Washer\/Disinfector, by Wassenburg Medical, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eAccessories, Cleaning, For Endoscope\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK241168\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e System 83 Revolve Endoscope Washer\/Disinfector\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Wassenburg Medical, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e876.15\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eFEB\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2024-04-26\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2024-12-19\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\u003eGeneral Hospital\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 5,773\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 4,931\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 842\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309545554084,"sku":"FDA510K241168","price":1985.42,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k241168","provider":"FOIA Document Source","version":"1.0","type":"link"}