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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)
Number
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Decision
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p-nitrophenyl phosphate Macomb Chemical Co. k801086 05/28/1980
mtone evo (mtone evo) M&T S.R.L. k240604 09/20/2024
rosebud dissector Lorrex Health Products k945332 12/05/1994
mts omadacycline 0.002 - 32 ug/ml Liofilchem s.r.l. k200180 03/20/2020
mustang, c.a.t. Lancer Orthodontics, Inc. k901957 07/30/1990
elite biofeedback Laborie Medical Technologies, Ltd. k942563 06/06/1995
basic recline chair Labac Systems, Inc. k941157 04/07/1994
samboro latex patient examination gloves Ktp Gloves Industrial Corp. k891643 05/31/1989
vifs Konica Medical Corp. k955583 05/14/1996
polaris bipolar electrosurgical generator (29-1000); polaris irrigation module (29-1600); polaris light source module (29-1900); dual footswitch (29-1020) Kirwan Surgical Products, LLC k231872 08/25/2023

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