{"product_id":"fda-510k-k081440","title":"FDA 510(k) K081440, BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES, by Smiths Medical Asd, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eTube Tracheostomy And Tube Cuff\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK081440\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Smiths Medical Asd, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e868.58\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eJOH\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2008-05-22\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2008-09-12\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eAnesthesiology\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eAnesthesiology\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 119\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 54\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 65\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309544636580,"sku":"FDA510K081440","price":248.35,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k081440","provider":"FOIA Document Source","version":"1.0","type":"link"}