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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 K163446
Device Name AxoGen Nerve Cap
AxoGen Corporation
13631 Progress Blvd
Alachua,  FL  32615
Applicant Contact Mark L. Friedman
New South Regulatory, LLC
223 Coventry Road
Decatur,  GA  30030
Correspondent Contact Wendy Perreault
Regulation Number882.5275
Classification Product Code
Date Received12/08/2016
Decision Date 08/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No