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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Applicant
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510(K)
Number
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Decision
Date
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wheelchair, mechanical series model 3100 MADA MEDICAL PRODUCTS, INC. k002943 10/23/2000
wallflex partially covered esophageal stent system BOSTON SCIENTIFIC CORP. k073266 02/27/2008
vyspan™ pct system Vy Spine, LLC k232167 09/27/2023
vygon enternal nutrition tubes EXCO, INC. k820176 02/05/1982
voxel dosimetry™ v1.0 Hermes Medical Solutions AB k191216 10/17/2019
vitek 2 gram positive gatifloxacin BIOMERIEUX, INC. k032314 08/22/2003
vitek 2 ast-streptococcus penicillin (<=0.06 - =>8 µg/ml), vitek 2 streptococcus penicillin (<=0.06 - >=8 µg/ml), vitek 2 streptococcus penicillin bioMerieux, Inc k232201 10/23/2023
vital sync informatics manager & virtual patient monitoring platform COVIDIEN k160718 11/14/2016
vital signs monitor w/arrhythmia detection and st analysis, model 8100 CRITICARE SYSTEMS, INC. k030613 04/17/2003
vital 5 releaf catheter VITAL 5 k122661 02/27/2013

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