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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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sunglasses Sun and Young Sunglasses Co., Ltd. k932940 09/20/1993
sunrunner te-777 Pride Health Care, Inc. k923193 07/17/1992
supascoota motorized vehicle - spartan (sumo)/ spartan sp (sumo sp) Eurogreen International, Inc. k182631 09/19/2019
sureset infusion set, model 8023 Applied Diabetes Research, Incorporated k012429 11/06/2001
surgical face mask Hunan Eexi Technology & Service Co., Ltd. k202161 03/10/2021
surgiclear antimicrobial clear silicone adhesive dressing with chlorhexidine and silver Covalontechnologies, Inc. k121819 08/13/2012
synelisa ana total Elias U.S.A., Inc. k935468 03/25/1994
syngo. ct single source dual energy (twin beam) Siemens Medical Solutions USA, Inc., Ultrasound DI k163289 02/09/2017
synthes 7.0/7.3 mm cannulated screws Synthes (Usa) k962011 08/05/1996
sysmex r-1000 automated reticulocyte analyzer Toa Medical Electronics USA, Inc. k894539 09/26/1989

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