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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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Applicant
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510(K)
Number
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Decision
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safety insulin needle for single use Berpu Medical Technology Co., Ltd. k181447 03/12/2019
slimming treatment device Beijing Honkon Technologies Co., Ltd. k161892 03/02/2017
pulse oximeter Beijing Choice Electronic Technology Co., Ltd. k220101 03/08/2023
bd phaseal optima closed system drug transfer device Becton, Dickinson and Company k201099 08/12/2020
meter, ph, digital, model 3560 Beckman Instruments, Inc. k770347 04/15/1977
interlink threaded lock cannula Bd k011858 06/19/2001
interlink system buretrol solution sets, interlink system buretrol solution sets, continued, clearlink system buretrol s Baxter Healthcare Corp k123874 01/10/2013
ngdi (next generation diagnostic instrument) Bausch & Lomb k040913 07/23/2004
premise series bed Batesville American Mfg. Co. k890845 06/15/1989
chlamydiae immunoperoxidase test kit Bartels Immunodiagnostic Supplies, Inc. k842151 07/20/1984

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