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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 K162934
Device Name Biodesign Parastomal Hernia Repair 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 Daniela I. Changkuon
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
FTL   OXK  
Date Received10/20/2016
Decision Date 07/10/2017
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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