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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, polymeric
510(k) Number K062697
Device Name SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
Applicant
COOK BIOTECH, INC.
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906 -1000
Applicant Contact MARY A FADERAN
Correspondent
COOK BIOTECH, INC.
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906 -1000
Correspondent Contact MARY A FADERAN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/11/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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