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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
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zoll x series ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS k112432 03/21/2012
yooeehouse breast pump Nantong Poly Technology Co., Ltd. k163183 10/02/2017
xplorer 1500 digital radiographic system with stand IMAGING DYNAMICS COMPANY LTD. k063246 11/22/2006
xawex g 100 WIELAND DENTAL + TECHNIK GMBH & CO. KG k050903 06/23/2005
x-suit nir biliary metallic stent MEDINOL LTD. k150487 02/12/2016
working element, resection button electrode for plasma vaporizaton, hf-resection electrode loops and bands OLYMPUS WINTER & IBE GMBH k100275 07/01/2010
wondfo amphetamine urine test (amp 300), wondfo methamphetamine urine test (met 500) Guangzhou Wondfo Biotech Co., Ltd. k122961 12/21/2012
wiener lab. urine strip 10 and 11 WIENER LABORATORIOS S.A.I.C. k083724 09/02/2009
wiener lab. standatrol s-e 2 niveles, lovels 1&2: 3x5 ml vials cat.nr.1937553 WIENER LABORATORIES k030482 03/19/2003
wieland zeno cao temporary pmma disc, tooth-colored MERZ DENTAL GMBH k071548 08/21/2007

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