Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft— 510(k) K191696

Name: FDA 510(k) clearance K191696
Creator: U.S. Food and Drug Administration
Published: 2019-12-27

Substantially Equivalent

Cook Biotech Incorporated

FDA 510(k) clearance K191696 for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft, Substantially Equivalent on 2019-12-27. Applicant: Cook Biotech Incorporated. Device class: 2.

Clearance details

Applicant: Cook Biotech Incorporated
Product code: Code OXN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2019-06-25
Decision date: 2019-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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