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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Self-Fitting Air-Conduction Hearing Aid, Over The Counter
510(k) Number K230538
Device Name All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
Applicant
Sonova AG
Laubisruetistrasse 28
Zurich,  CH 8712
Applicant Contact Nelson Hu
Correspondent
Hymann, Phelps, & Mcnamara P.C.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Correspondent Contact Philip J.H. Won
Regulation Number874.3325
Classification Product Code
QUH  
Date Received02/27/2023
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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