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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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sodem high speed system (electric) (general orthopedics & plastic surgery) SODEM SYSTEMS k012453 10/22/2001
smoothshapes BICELLULASE, INC. k053611 03/15/2006
smartgrid Carestream Health k163157 03/21/2017
small volume nebulizer ALLEGIANCE HEALTHCARE CORPORATION k023602 05/01/2003
single use cytology brush Zhejiang Chuangxiang Medical Technology Co., Ltd. k220063 07/28/2022
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
simplicity infusion pump model 2100a CRITIKON COMPANY,LLC k803078 01/28/1981
silver shield antimicrobial skin and wound gel, model 3015-s ANACAPA TECHNOLOGIES, INC. k062212 11/21/2006
signafuse bioactive strip (sbs); signafuse putty Bioventus LLC k233490 12/05/2023
sientra opus silicone gel breast implant sizer Sientra, Inc k200706 11/16/2020

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