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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 K875009
Device Name IN-THE-EAR HEARING AID
Applicant
House of Hearing Aids, Ltd.
6047 W. Belmont Ave.
Chicago,  IL  60634
Applicant Contact EDWARD J TAHENY
Correspondent
House of Hearing Aids, Ltd.
6047 W. Belmont Ave.
Chicago,  IL  60634
Correspondent Contact EDWARD J TAHENY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/04/1987
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
Predetermined Change
Control Plan Authorized		 No
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