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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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Applicant
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510(K)
Number
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Decision
Date
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neuroflax, epk Franks Electronics k831990 11/28/1983
new cobe centrysystem(tm) 100 hg dialyzer Cobe Laboratories, Inc. k904566 12/12/1990
new england medical grounding pad New England Medical, Inc. k931982 10/05/1993
new era orthopaedics polyscrew pedicle screw system New Era Orthopaedics, LLC k141253 01/09/2015
nexus tko-6, luer-activated device Nexus Medical, LLC k113398 04/18/2012
nexwave combo muscle stimulator system Zynex Medical, Inc. k111279 09/20/2011
ngdi (next generation diagnostic instrument) Bausch & Lomb k040913 07/23/2004
nitrile examination gloves Niujian Technology Co., Ltd. k210706 10/19/2021
nobelreplace adapter, model 32412 Nobel Biocare Uas, Inc. k050444 07/07/2005
noninvasive electronic digital bp monitor ebm-1050 Unisonic Products Corp. k850476 04/29/1985

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