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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K984243
Device Name TELEX TINNITUS-COMPANION
Applicant
Telex Communications, Inc.
9600 Aldrich Ave. S.
Minneapolis,  MN  55420
Applicant Contact TOM SCHELLER
Correspondent
Telex Communications, Inc.
9600 Aldrich Ave. S.
Minneapolis,  MN  55420
Correspondent Contact TOM SCHELLER
Regulation Number874.3400
Classification Product Code
KLW  
Date Received11/27/1998
Decision Date 01/21/1999
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
Predetermined Change
Control Plan Authorized		 No
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