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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, Diaphragmatic Hernia
510(k) Number K133011
Device Name DIAPHRAGMATIC HERNIA GRAFT
Applicant
Cook Biotech, Inc.
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact MARY A FADERAN PH.D., RAC
Correspondent
Cook Biotech, Inc.
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact MARY A FADERAN PH.D., RAC
Regulation Number878.3300
Classification Product Code
OWV  
Subsequent Product Code
FTM  
Date Received09/25/2013
Decision Date 06/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT00272922
NCT00786084
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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