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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K183110
Device Name LIVIA
Applicant
LifeCare Ltd.
Zipori St.2
Tiberias,  IL 1424602
Applicant Contact Amnon Nahum Sharon
Correspondent
Cohen, Tauber, Spievack & Wagner
420 Lexington Avenue - Suite 2400
New York,  NY  10170
Correspondent Contact Irving L. Wiesen
Regulation Number882.5890
Classification Product Code
NUH  
Date Received11/08/2018
Decision Date 05/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03064945
Reviewed by Third Party No
Combination Product No
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