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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 K880635
Device Name IN THE EAR HEARING AID
Applicant
TALLAHASSEE HEARING AID CENTER
903 NORTH MONROE ST.
TALLAHASSEE,  FL  32303
Applicant Contact BARBARA R STANLEY
Correspondent
TALLAHASSEE HEARING AID CENTER
903 NORTH MONROE ST.
TALLAHASSEE,  FL  32303
Correspondent Contact BARBARA R STANLEY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/16/1988
Decision Date 03/09/1988
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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