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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 K251505
Device Name VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
Applicant
Alafair Biosciences
6101 W Courtyard Dr.
Suite 1-225
Austin,  TX  78730
Applicant Contact Sarah Mayes
Correspondent
Alafair Biosciences
6101 W Courtyard Dr.
Suite 1-225
Austin,  TX  78730
Correspondent Contact Sarah Mayes
Regulation Number882.5275
Classification Product Code
JXI  
Date Received05/16/2025
Decision Date 07/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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