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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 K133306
Device Name SIS HERNIA GRAFT
Applicant
COOK BIOTECH, INC.
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Applicant Contact PERRY W GUINN
Correspondent
COOK BIOTECH, INC.
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Correspondent Contact PERRY W GUINN
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
OXK  
Date Received10/28/2013
Decision Date 07/23/2014
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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