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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 K061111
Device Name TINNITUS PHASE-OUT
Applicant
Tinnitus Control, Inc.
719 A St. NE
Washington,  DC  20002
Applicant Contact RUSS PAGANO
Correspondent
Tinnitus Control, Inc.
719 A St. NE
Washington,  DC  20002
Correspondent Contact RUSS PAGANO
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/21/2006
Decision Date 05/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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