{"product_id":"fda-510k-k203362","title":"FDA 510(k) K203362, TRACOE vario, by Tracoe Medical GmbH","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eTube Tracheostomy And Tube Cuff\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK203362\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e TRACOE vario\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Tracoe Medical GmbH\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e868.5800\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eJOH\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e11\/16\/2020\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 08\/05\/2021\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 2,523\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 1,973\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 550\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313221206180,"sku":"FDA510K203362","price":1394.11,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k203362","provider":"FOIA Document Source","version":"1.0","type":"link"}