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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 K151558
Device Name Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
Applicant
Neurotherapies Reset GmbH
Karl-Heinz-Beckhurts-Srt.13
Juelich,  DE D-52428
Applicant Contact MICHAEL PELHAM MORRIS OLIVE
Correspondent
Deborah L. Sheffield Consulting
5672 Flagler Rd.
Nordland,  WA  98358
Correspondent Contact DEBORAH SHEFFIELD
Regulation Number874.3400
Classification Product Code
KLW  
Date Received06/10/2015
Decision Date 01/20/2016
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
Predetermined Change
Control Plan Authorized		 No
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