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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 K070599
Device Name CUSTOMIZED SOUND THERAPY (CST)
Applicant
Tinnitus Otosound Products, LLC
880 First St., Suite 403
Los Angeles,  CA  90012
Applicant Contact GERALDINE CREAN
Correspondent
Tinnitus Otosound Products, LLC
880 First St., Suite 403
Los Angeles,  CA  90012
Correspondent Contact GERALDINE CREAN
Regulation Number874.3400
Classification Product Code
KLW  
Date Received03/02/2007
Decision Date 07/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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