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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, Group And Auditory Trainer
510(k) Number K913494
Device Name TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC
Applicant
TELEX COMMUNICATIONS, INC.
9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS,  MN  55420
Applicant Contact THOMAS J LAKE
Correspondent
TELEX COMMUNICATIONS, INC.
9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS,  MN  55420
Correspondent Contact THOMAS J LAKE
Regulation Number874.3320
Classification Product Code
EPF  
Date Received08/06/1991
Decision Date 11/01/1991
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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