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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 K982432
Device Name PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-
Applicant
Tinnitus Treatment Centers, Inc.
8215 Westchester, Suite 150
Dallas,  TX  75225 -6109
Applicant Contact DAVID W HOLMES
Correspondent
Tinnitus Treatment Centers, Inc.
8215 Westchester, Suite 150
Dallas,  TX  75225 -6109
Correspondent Contact DAVID W HOLMES
Regulation Number874.3400
Classification Product Code
KLW  
Subsequent Product Code
ESD  
Date Received07/13/1998
Decision Date 01/25/1999
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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