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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 K043274
Device Name NEUROMONICS TINNITUS TREATMENT
Applicant
NEUROMONICS PTY LTD
UNIT 10-11/56 NERIDAH ST
CHATSWOOD,  AU NSW 2067
Applicant Contact BEN MCSWEENEY
Correspondent
NEUROMONICS PTY LTD
UNIT 10-11/56 NERIDAH ST
CHATSWOOD,  AU NSW 2067
Correspondent Contact BEN MCSWEENEY
Regulation Number874.3400
Classification Product Code
KLW  
Date Received11/26/2004
Decision Date 01/28/2005
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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