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U.S. Department of Health and Human Services

510(K) Premarket Notification

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infrared thermometer models: dt-8806s, dt-8807s Shenzhen Everbest Machinery Industry Co., LTD k203170 04/16/2021
reusable and self-adhesive electrodes Shaoxing DongZhi Electrical Technology Co., Ltd. k180773 05/22/2018
nitrile exam glove, pre-powdered, color blue SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. k002220 08/15/2000
disposable vinyl examination gloves, yellow color, powder free with vitamin e SHANGHAI ANTARES INDUSTRIES, INC. k021853 08/01/2002
non absorbable surgical nylon suture Shandong Haidike Medical Product Co., Ltd. k212603 12/22/2021
bone fixaction screw SERRANO INTL. k810497 03/11/1981
sentinel ceruloplasmin SENTINEL CH. SRL k051456 10/21/2005
sentec digital monitoring system SENTEC AG k071672 09/12/2007
arm-type fully automatic digital blood pressure monitor SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. k161577 02/08/2017
insufflator Scivita Medical Technology Co., Ltd. k222812 05/16/2023

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