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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 K163153
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 Received11/10/2016
Decision Date 06/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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