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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 K872552
Device Name HEARING-AID
Applicant
Audio-Technica U.S., Inc.
1221 Commerce Dr.
Stow,  OH  44224
Applicant Contact GERALD A BLOCH
Correspondent
Audio-Technica U.S., Inc.
1221 Commerce Dr.
Stow,  OH  44224
Correspondent Contact GERALD A BLOCH
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/29/1987
Decision Date 08/03/1987
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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