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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 K200311
Device Name VersaWrap Tendon Protector
Applicant
Alafair Biosciences Inc
6101 W Courtyard Drive ste 2-225
Austin,  TX  78730
Applicant Contact Ben Walthall
Correspondent
NAMSA
400 Highway 169 South, Ste 500
Minneapolis,  MN  55426
Correspondent Contact Angela Mallery
Regulation Number878.3300
Classification Product Code
FTM  
Date Received02/06/2020
Decision Date 03/06/2020
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
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