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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 K213163
Device Name VersaWrap
Applicant
Alafair Biosciences, Inc.
6101 W Courtyard Dr.
Suite 2-225
Austin,  TX  78730
Applicant Contact Angela Mallery
Correspondent
Alafair Biosciences, Inc.
6101 W Courtyard Dr.
Suite 2-225
Austin,  TX  78730
Correspondent Contact Angela Mallery
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/28/2021
Decision Date 10/29/2021
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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