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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, collagen, fistula
510(k) Number K191696
Device Name Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
Applicant
Cook Biotech Incorporated
1425 Innovation Place
West Lafayette,  IN  47906
Applicant Contact Perry W. Guinn
Correspondent
Cook Biotech Incorporated
1425 Innovation Place
West Lafayette,  IN  47906
Correspondent Contact Nick Wang
Regulation Number878.3300
Classification Product Code
OXN  
Subsequent Product Codes
FTM   OXH  
Date Received06/25/2019
Decision Date 12/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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