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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 K030791
Device Name ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
Applicant
Tinnitech, Ltd.
55 Market St.
Level 2
Sydney,  AU NSW 2000
Applicant Contact LACHLAN JAMES
Correspondent
Tinnitech, Ltd.
55 Market St.
Level 2
Sydney,  AU NSW 2000
Correspondent Contact LACHLAN JAMES
Regulation Number874.3400
Classification Product Code
KLW  
Date Received03/12/2003
Decision Date 04/17/2003
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
Predetermined Change
Control Plan Authorized		 No
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