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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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revcore™ thrombectomy catheter. Inari Medical, Inc. k223609 03/14/2023
electric wheelchair Shanghai BangBang Robotics Co., Ltd. k223393 03/16/2023
evis x1 video system center olympus cv-1500, colonovideoscope olympus cf-hq1100dl/i, gastrointestinal videoscope olympus gif-1100 Olympus Medical Systems Corporation k222584 04/26/2023
dental desensitizer Guangzhou Beogene Biotech Co., Ltd k222891 05/25/2023
victan Jiangsu Haize Medical Scientific Development Co., Ltd. k230593 05/30/2023
skinstylus sterilock® microsystem, model number mp1209sl Esthetic Medical Inc. k231073 07/28/2023
expd 4357; expd 4357p DRTECH Corporation k231959 08/01/2023
digital blood pressure monitor wbp series Weony (Shenzhen) Technology Co., Ltd. k231542 09/07/2023
hantech pre-filled 0.9% normal saline flush syringes (models pfs-1003, pfs-1005, pfs-1010) Hantech Medical Device Co., Ltd. k231363 09/27/2023
laser cap, model: hat-01 Hubei YJT Technology Co.,Ltd k232356 10/24/2023

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