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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 K130937
Device Name WAVE 2G, SOUL
Applicant
HANSATON AKUSTIK GMBH
BEIM STROHHAUSE 17
HAMBURG,  DE 20097
Applicant Contact NICK BURMESTER
Correspondent
HANSATON AKUSTIK GMBH
BEIM STROHHAUSE 17
HAMBURG,  DE 20097
Correspondent Contact NICK BURMESTER
Regulation Number874.3400
Classification Product Code
KLW  
Date Received04/04/2013
Decision Date 01/03/2014
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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