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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 K875010
Device Name IN-THE-EAR HEARING AID
Applicant
STATCO HEARING AID LABORATORY
4505 J.F.K. BLVD.
N. LITTLE ROCK,  AR  72116
Applicant Contact ED STATON
Correspondent
STATCO HEARING AID LABORATORY
4505 J.F.K. BLVD.
N. LITTLE ROCK,  AR  72116
Correspondent Contact ED STATON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/04/1987
Decision Date 02/23/1988
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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