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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, Staple Line Reinforcement
510(k) Number K022044
Device Name SURGISIS STAPLE LINE REINFORCEMENT
Applicant
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906
Applicant Contact MARK BLEYER
Correspondent
Cook Biotech, Inc.
3055 Kent Ave.
West Lafayette,  IN  47906
Correspondent Contact MARK BLEYER
Regulation Number878.3300
Classification Product Code
OXE  
Subsequent Product Codes
FTM   PAJ  
Date Received06/24/2002
Decision Date 08/23/2002
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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