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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 K170945
Device Name Biodesign Staple Line Reinforcement
Applicant
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Applicant Contact Perry W. Guinn
Correspondent
Cook Biotech Incorporated
1425 Innovation Pl.
West Lafayette,  IN  47906
Correspondent Contact Daniela I. Changkuon
Regulation Number878.3300
Classification Product Code
OXE  
Subsequent Product Code
FTM  
Date Received03/30/2017
Decision Date 04/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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