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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 K880938
Device Name ITE TYPE HEARING AID ABS MODEL
Applicant
A BETTER SOUND CORP.
1151 S. LACANADA, STE. A-204
GREEN VALLEY,  AZ  85614
Applicant Contact ROBERT C BARE
Correspondent
A BETTER SOUND CORP.
1151 S. LACANADA, STE. A-204
GREEN VALLEY,  AZ  85614
Correspondent Contact ROBERT C BARE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/07/1988
Decision Date 05/13/1988
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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