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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 K171817
Device Name Biodesign Diaphragmatic Hernia Graft
Applicant
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact Perry W. Guinn
Correspondent
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact Nick X. Wang
Regulation Number878.3300
Classification Product Code
FTM  
Date Received06/19/2017
Decision Date 03/13/2018
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
Predetermined Change
Control Plan Authorized		 No
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