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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 K201631
Device Name VersaWrap Nerve Protector
Applicant
Alafair Biosciences Inc
6101 W Courtyard Drive ste 2-225
Austin,  TX  78730
Applicant Contact Angela Mallery
Correspondent
Namsa
400 Highway 169 South, Ste 500
Minneapolis,  MN  55426
Correspondent Contact Angela Mallery
Regulation Number882.5275
Classification Product Code
JXI  
Date Received06/16/2020
Decision Date 09/14/2020
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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