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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 K870435
Device Name MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID
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 Received02/03/1987
Decision Date 03/11/1987
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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