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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K843712
Device Name AUDIT TM V
Applicant
Axonics , Inc.
1500 Salado Dr.
Mountain View,  CA  94043 -
Applicant Contact JOHN LEE
Correspondent
Axonics , Inc.
1500 Salado Dr.
Mountain View,  CA  94043 -
Correspondent Contact JOHN LEE
Regulation Number882.1870
Classification Product Code
GWF  
Date Received09/21/1984
Decision Date 04/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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