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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 K201000
Device Name Biodesign Staple Line Reinforcement
Applicant
Cook Biotech Incorporated
1425 Innovation Place
West Lafayette,  IN  47906
Applicant Contact Nick Wang
Correspondent
Cook Biotech Incorporated
1425 Innovation Place
West Lafayette,  IN  47906
Correspondent Contact Chris Lotzow
Regulation Number878.3300
Classification Product Code
FTM  
Date Received04/16/2020
Decision Date 07/13/2020
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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