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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, electro-acupuncture
510(k) Number K152571
Device Name Stivax
Applicant
BIEGLER GMBH
ALLHANGSTRASSE 18A
MAUERBACH,  AT 3001
Applicant Contact FRIEDRICH NETAUSCHEK
Correspondent
PROMEDIC, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Classification Product Code
BWK  
Date Received09/09/2015
Decision Date 05/26/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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