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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 K881193
Device Name ACCUTONE IN-THE-EAR HEARING AID
Applicant
INTERSTATE HEARING AID SERVICE
15 PUBLIC SQUARE
WILKES BARRE,  PA  18701
Applicant Contact JAMES CULP
Correspondent
INTERSTATE HEARING AID SERVICE
15 PUBLIC SQUARE
WILKES BARRE,  PA  18701
Correspondent Contact JAMES CULP
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/21/1988
Decision Date 05/18/1988
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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