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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, prescription
510(k) Number K922827
Device Name OTOSONIC ACS K
Applicant
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Applicant Contact ROBERT A KRATOCHVIL
Correspondent
BELTONE ELECTRONICS CORP.
4201 WEST VICTORIA ST.
CHICAGO,  IL  60646
Correspondent Contact ROBERT A KRATOCHVIL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/12/1992
Decision Date 07/01/1992
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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