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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 K231708
Device Name Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
Applicant
AxoGen Corporation
13631 Progress Blvd, Ste 400
Alachua,  FL  32615 -9409
Applicant Contact Shravani Shastry
Correspondent
AxoGen Corporation
13631 Progress Blvd, Ste 400
Alachua,  FL  32615 -9409
Correspondent Contact Shravani Shastry
Regulation Number882.5275
Classification Product Code
JXI  
Date Received06/12/2023
Decision Date 10/12/2023
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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