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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 K013827
Device Name TST - SUPPRESSOR MODEL #1000
Applicant
NEUROSIM LIMITED
13 FUCHSIA ST.
BLACKBURN 3130
VICTORIA,  AU 3130
Applicant Contact IAN BROWN
Correspondent
NEUROSIM LIMITED
13 FUCHSIA ST.
BLACKBURN 3130
VICTORIA,  AU 3130
Correspondent Contact IAN BROWN
Regulation Number874.3400
Classification Product Code
KLW  
Date Received11/19/2001
Decision Date 05/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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