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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
510(k) Number K070405
Device Name MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
Applicant
COOK BIOTECH, INC.
1400 CUMBERLAND AVE.
WEST LAFAYETTE,  IN  47906
Applicant Contact DANIEL J DILLON
Correspondent
COOK BIOTECH, INC.
1400 CUMBERLAND AVE.
WEST LAFAYETTE,  IN  47906
Correspondent Contact DANIEL J DILLON
Regulation Number878.3300
Classification Product Code
FTM  
Date Received02/12/2007
Decision Date 10/17/2007
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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