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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hearing aid, air conduction
510(k) Number K874385
Device Name AUDIOTONE MODEL MSP, IN-THE-EAR HEARING AID
Applicant
AUDIOTONE, INC.
p.o. box 2905
phoenix,  AZ  85062
Applicant Contact dave larson
Correspondent
AUDIOTONE, INC.
p.o. box 2905
phoenix,  AZ  85062
Correspondent Contact dave larson
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/26/1987
Decision Date 01/07/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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