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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 1076
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 (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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