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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 K853264
Device Name HEARING AID MODEL 337D
Applicant
TELEX COMMUNICATIONS, INC.
9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS,  MN  55420
Applicant Contact HARRY TEDER
Correspondent
TELEX COMMUNICATIONS, INC.
9600 ALDRICH AVENUE SOUTH
MINNEAPOLIS,  MN  55420
Correspondent Contact HARRY TEDER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/05/1985
Decision Date 09/23/1985
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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