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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
Original Applicant
COOK BIOTECH, INC.
3055 kent ave.
west lafayette,  IN  47906 -1076
Original 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
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