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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 K982683
Device Name TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
Applicant
TELEX COMMUNICATIONS, INC.
9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS,  MN  55420
Applicant Contact TOM SCHELLER
Correspondent
TELEX COMMUNICATIONS, INC.
9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS,  MN  55420
Correspondent Contact TOM SCHELLER
Regulation Number874.3320
Classification Product Code
EPF  
Subsequent Product Code
ESD  
Date Received07/31/1998
Decision Date 10/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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