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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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powder-free nitrile examination glove tested for use with chemotherapy drugs and fentanyl (white, blue, black, orange and green color) Encompass Industries Sdn. Bhd. k220609 05/27/2022
consolidated hc steam sterilizer Consolidated Machine Corp. k220736 08/01/2022
dental zirconia blank & dental zirconia pre-shaded blank Changsha Honchon Technology Co., LTD k221051 07/08/2022
filter and hme/filter Ningbo Huakun Medical Equipment Co., Ltd. k221472 02/08/2023
accuicas ArteryFlow Technology Co., Ltd. k221711 02/28/2023
electric wheelchair, model: 9000n Silver Fox Corporation Limited k221799 09/16/2022
surgical mask (gfm 96, gfm 91, gfm 90, gfm 88, gfm 81, gfm 80) Jingzhou Haixin Green Cross Medical Products Co.,Ltd. k222266 09/26/2022
hurrichem device kit ThermaSolutions LLC k222575 12/06/2022
denu light body(regular, fast), denu heavy body(regular, fast), denu putty set(regular, fast) HDI, Inc. k222741 11/07/2022
arial dental, mistral dental amalgam, world work dental amalgam, bms non gamma 2 alloy, flexi alloy, hi-s alloy, ww dental amalgam, hi - mix, non gamma 2 alloy WorldWork S.R.L k223182 05/01/2023

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