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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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nitrile examination gloves Niujian Technology Co., Ltd. k210706 10/19/2021
ngdi (next generation diagnostic instrument) Bausch & Lomb k040913 07/23/2004
nexwave combo muscle stimulator system Zynex Medical, Inc. k111279 09/20/2011
nexus tko-6, luer-activated device Nexus Medical, LLC k113398 04/18/2012
new era orthopaedics polyscrew pedicle screw system New Era Orthopaedics, LLC k141253 01/09/2015
new england medical grounding pad New England Medical, Inc. k931982 10/05/1993
new cobe centrysystem(tm) 100 hg dialyzer Cobe Laboratories, Inc. k904566 12/12/1990
neuroflax, epk Franks Electronics k831990 11/28/1983
nalu neurostimulation system for spinal cord stimulation; nalu neurostimulation system for peripheral nerve stimulation Nalu Medical, Inc. k233801 08/23/2024
myotest nerve stimulator Prothia USA, Inc. k823583 12/30/1982

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