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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, Absorbable, Orthopaedics, Reinforcement Of Tendon
510(k) Number K160364
FOIA Releasable 510(k) K160364
Device Name VersaWrap Tendon Protector
Applicant
Alafair Biosciences, Inc.
3925 W. Braker Ln., Floor #3
Austin,  TX  78759
Applicant Contact Ben Walthall
Correspondent
Alafair Biosciences, Inc.
3925 W. Braker Ln., Floor #3
Austin,  TX  78759
Correspondent Contact Ben Walthall
Regulation Number878.3300
Classification Product Code
OWW  
Date Received02/09/2016
Decision Date 06/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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