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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 K031624
Device Name TINNITUS RX
Applicant
TINNITUS CONTROL, INC.
719 A STREET, NE
WASHINGTON,  DC  20002
Applicant Contact RUSS PAGANO
Correspondent
TINNITUS CONTROL, INC.
719 A STREET, NE
WASHINGTON,  DC  20002
Correspondent Contact RUSS PAGANO
Regulation Number874.3400
Classification Product Code
KLW  
Date Received05/23/2003
Decision Date 07/24/2003
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
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