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U.S. Department of Health and Human Services

510(K) Premarket Notification
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pulse oximeter Shenzhen Yimi Life-Technology Co.,Ltd. k191430 10/18/2019
sterilucent vh2o2 chemical indicators Sterilucent, Inc. k191999 10/21/2019
turnsignal stopcocks sterile, turnsignal stopcocks buld non sterile, turnsignal stopcocks with manifolds sterile, turnsignal stopcocks with manifolds bulk non sterile MonuMedical, LLC k190539 10/22/2019
nebula brand locking bone plates and screws osteosynthesis plating system, nebula brand of dhs plating system Nebula Surgical Private Limited k191793 12/09/2019
disposable powder free nitrile examination glove, tested for use with chemotherapy drugs, white color, disposable powder free nitrile examination glove, tested for use with chemotherapy drugs, orange color Ever Growth (Vietnam) Co. Ltd. k190860 12/23/2019
single use guide sheath kit k-401, k-402, & single use guiding device cc-220dr Olympus Medical Systems Corp. k192164 03/06/2020
aneroid sphygmomanometer with stethoscope, aneroid sphygmomanometer Honsun(Nantong)Co.,Ltd k192500 04/06/2020
nuvo nano portable oxygen concentrator Nidek Medical Products, Inc. k192693 05/07/2020
bp-bt kiosk LD Technology LLC k200287 05/15/2020
automatic upper arm blood pressure monitor Dongguan E-Test Technology Co., Ltd k193624 07/10/2020

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