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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conditioner, Signal, Physiological
510(k) Number K833298
Device Name AUDIT V AX 135
Applicant
AXONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AXONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1845
Classification Product Code
GWK  
Date Received09/23/1983
Decision Date 12/01/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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