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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 K051048
Device Name SURGISIS STAPLE LINE REINFORCEMENT II
Applicant
Cook Biotech, Inc.
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact MARK BLEYER
Correspondent
Cook Biotech, Inc.
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact MARK BLEYER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/25/2005
Decision Date 09/23/2005
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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