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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 K942830
Device Name HAE 3
Applicant
HEARING AID EXPRESS
5137 BELLAIRE
BELLAIRE,  TX  77401
Applicant Contact MARK BRUMBACK
Correspondent
HEARING AID EXPRESS
5137 BELLAIRE
BELLAIRE,  TX  77401
Correspondent Contact MARK BRUMBACK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/14/1994
Decision Date 07/20/1994
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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