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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
510(k) Number K161221
Device Name Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
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 Perry W. Guinn
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/29/2016
Decision Date 05/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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