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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K232029
Device Name VersaWrap Nerve Protector
Applicant
Alafair Biosciences Inc
6101 W Courtyard Drive, Ste. 2-225
Austin,  TX  78730
Applicant Contact Angela Mallery
Correspondent
Alafair Biosciences Inc
6101 W Courtyard Drive, Ste. 2-225
Austin,  TX  78730
Correspondent Contact Angela Mallery
Regulation Number882.5275
Classification Product Code
JXI  
Date Received07/07/2023
Decision Date 11/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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