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U.S. Department of Health and Human Services

510(K) Premarket Notification
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picosecond laser system (model ps10-a and ps10-b) Beijing ADSS Development Co., Ltd. k220268 08/23/2022
35g standard smms surgical gown; 35g reinforced smms surgical gown;43g standard smms surgical gown;43g reinforced smms surgical gown ;50g standard smms surgical gown; 50g reinforced smms surgical gown;bvb surgical gown Winner Medical Co., Ltd. k221819 09/19/2022
tp orthodontics light-cure adhesive system, tp orthodontics pre-applied adhesive, tp orthodontics etchant208520 TP Orthodontics, Inc. k214054 10/14/2022
bodygard sfs surgical gown level 4 Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri k221139 11/10/2022
auxilock gfs mini, gfs ii large, and gfs ultimate Auxein Medical Private Limited k213018 11/18/2022
marvel™ growing rods Globus Medical Inc. k213196 12/19/2022
4cis black marlin plif cage system, 4cis dolphin tlif cage system Solco Biomedical Company India Private Limited k213653 12/19/2022
advanced intramedullary nail system Double Medical Technology Inc. k221221 12/21/2022
well-life probe electrode for stimulation/emg probe (model: sa), well-life incontinence stimulation/emg electrode probe, well-life probe electrode Well-Life Healthcare Limited k222528 12/29/2022
power acute triple lumen hemodialysis catheter Health Line International Corporation k222170 01/13/2023

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