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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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ez-traxtm persona knee containment device K1 Medical LLC k211007 07/01/2021
dental impression material Nanchang Dental Bright Technology Co., Ltd k211489 07/28/2021
atlas one step hcg urine pregnancy test (strip), atlas one step hcg urine pregnancy test (cassette), atlas one step hcg urine pregnancy test (midstream) Atlas Link Technology Co., Ltd. k203246 08/04/2021
surgical face mask (model: cm2006, cm2008, a88) Shenzhen RealTone Medical Appliance Co., Ltd. k210878 09/28/2021
nitrile examination gloves Fitone Latex Products Co., Ltd. Guangdong k211927 10/12/2021
family of venus rf systems - venus freedom Venus Concept USA Inc. k211461 10/14/2021
medical face masks, model name:my020003 Huizhou Jie Bai Purification Co.,Ltd. k211165 11/09/2021
air compression therapy system fo3002 Foshan Hongfeng Co., Ltd. k212169 11/23/2021
nitrile examination gloves (tested for use with chemotherapy drugs) 5R MED Instruments (CHENGDU) Co., Ltd. k212789 12/01/2021
nitrile patient examination gloves (tested for use with chemotherapy drugs) Yunnan Huazhiyuan Medical Technology Co., Ltd. k213051 12/18/2021

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