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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 K170016
Device Name Biodesign 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 Nick Wang
Regulation Number878.3300
Classification Product Code
FTM  
Date Received01/03/2017
Decision Date 06/21/2017
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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