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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 K945710
Device Name IN-THE-EAR HEARING AID
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 Received11/21/1994
Decision Date 12/23/1994
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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