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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 K954236
Device Name FACEPLATE (HEARING AID KIT)
Applicant
TRUETONE HEARING SYSTEMS, INC.
829 15TH ST.
MOLINE,  IL  61265
Applicant Contact CHARLES GILMORE
Correspondent
TRUETONE HEARING SYSTEMS, INC.
829 15TH ST.
MOLINE,  IL  61265
Correspondent Contact CHARLES GILMORE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/11/1995
Decision Date 12/06/1995
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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