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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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dragon heart i.v. set DRAGON HEART MEDICAL DEVICES CO., LTD. k043235 03/08/2005
dss stabilization system PARADIGM SPINE k080963 05/02/2008
dual pedestal table PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. k811969 08/13/1981
dualflex rx ercp cannula, models 4681, 4682 BOSTON SCIENTIFIC CORP. k041827 08/06/2004
easyscreen gastrointestinal parasite detection kit Genetic Signatures Limited k232672 05/29/2024
eba one nailing system CITIEFFE S.r.l. k183666 11/14/2019
ebi trochanteric nail system EBI, L.P. k050118 02/16/2005
ebv vca-p18 igg elisa PANBIO LIMITED k030863 06/27/2003
ecg cables and leadwires Xinkang Medical Instrument Co., Ltd k201359 10/01/2020
eclipse treatment planning system VARIAN MEDICAL SYSTEMS, INC. k133247 02/07/2014

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