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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 K915397
Device Name TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER
Applicant
Telex Communications, Inc.
9600 Aldrich Ave. S.
Minneapolis,  MN  55420
Applicant Contact THOMAS LAKE
Correspondent
Telex Communications, Inc.
9600 Aldrich Ave. S.
Minneapolis,  MN  55420
Correspondent Contact THOMAS LAKE
Regulation Number874.3320
Classification Product Code
EPF  
Date Received11/29/1991
Decision Date 01/17/1992
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
Predetermined Change
Control Plan Authorized		 No
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