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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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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
dextrolyte ii, w/5 prong manifold no. 48-1003-2 National Medical Care, Medical Products Div., Inc. k900142 03/22/1990
maxi-tan device National Biological Corp. k864546 01/09/1987
the saver kit Myocure, Inc. k863666 10/20/1986
tem 3000 head coil Mr Instruments, Inc. k052200 08/19/2005
suction tip cleaner cup Moore/Gobel k952219 11/15/1995
atama system Monteris Medical, Inc. k110411 04/08/2011
minnesota medical technologies fecal incontinence insert (my miracle) Minnesota Medical Technologies k243367 07/22/2025
db push-pull hearing aid Midwest City Hearing Aid Center k953036 07/21/1995

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