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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 K874831
Device Name AUDIOTONE MODEL A2000 BEHIND-THE-EAR HEARING AID
Applicant
DAHLBERG ELECTRONICS, INC.
7731 COUNTRY CLUB DR.
GOLDEN VALLEY,  MN  55427
Applicant Contact BRENDA L DEARING
Correspondent
DAHLBERG ELECTRONICS, INC.
7731 COUNTRY CLUB DR.
GOLDEN VALLEY,  MN  55427
Correspondent Contact BRENDA L DEARING
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/24/1987
Decision Date 02/22/1988
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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