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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Face Plate Hearing Aid
510(k) Number K910901
Device Name FACEPLATE ITE HEARING AID MODEL 28A
Applicant
Telex Communications, Inc.
9600 Aldrich Ave. S.
Minneapolis,  MN  55420
Applicant Contact HARRY TEDER
Correspondent
Telex Communications, Inc.
9600 Aldrich Ave. S.
Minneapolis,  MN  55420
Correspondent Contact HARRY TEDER
Regulation Number874.3300
Classification Product Code
LRB  
Date Received03/05/1991
Decision Date 05/30/1991
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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