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U.S. Department of Health and Human Services

510(K) Premarket Notification
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planar led mate Shenzhen Leaflife Technology Co., Ltd k230362 09/11/2023
m9/m9cv/m9t/m8 elite/m10/m10cv/crius m10/m11/m11cv/crius m11/operus m11/m9 premium diagnostic ultrasound system Shenzhen Mindray Bio-Medical Electronics Co.,LTD k230768 06/09/2023
dental desensitizer Guangzhou Beogene Biotech Co., Ltd k222891 05/25/2023
ilet® ace pump Beta Bionics, Inc k223846 05/19/2023
insufflator Scivita Medical Technology Co., Ltd. k222812 05/16/2023
deep learning image reconstruction GE Healthcare Japan Corporation k230807 04/20/2023
intense pulsed light (ipl) system, model: t023k, t023a, t023b, t023c, t023d, t023e, t021k, t021a, t001a, t001b, t001m, t001n, t011c, t016k Shenzhen Fansizhe Science And Technology Co., Ltd k223928 03/28/2023
inteross collagen SigmaGraft Inc. k221808 03/18/2023
iexaminer system with panoptic plus Welch Allyn, Inc. k223381 03/15/2023
external drainage system JMED(Shenzhen) Technology Limited k221694 02/09/2023

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