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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 K111695
Device Name HYBRID GRAFT
Applicant
COOK BIOTECH, INC.
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906 -1000
Applicant Contact MARY A FADERAN, PHD, RAC
Correspondent
COOK BIOTECH, INC.
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906 -1000
Correspondent Contact MARY A FADERAN, PHD, RAC
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/16/2011
Decision Date 04/02/2012
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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