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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 K931157
Device Name BEHIND-THE-EAR HEARING AID, TELEX MODEL 380-PP
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 Received03/08/1993
Decision Date 04/14/1993
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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