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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 K982451
Device Name TTCGHI-T AND TTCTN3-T-T
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  
Date Received07/15/1998
Decision Date 05/07/1999
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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