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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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solax powered wheelchair Dongguan Prestige Sporting Goods Co., Ltd k182576 05/21/2019
smartct r1.0 Philips Medical Systems, Nederland B.V. k201583 02/09/2021
smartband emr kit (sb-emr-k, sb-emr-k-12, sb-emr-k-9.4), smartband emr pack (sb-emr-p, sb-emr-p-12, sb-emr-p-9.4), smartsnare emr hexagonal snare (ss-230-1 or packaged with kit) Steris Corporation k212860 10/07/2021
smart muscle training wearables (model:sm9027,sm9027,sm9566,sm9065n) Chongqing Rob Linka Science And Technology Co., Ltd. k233070 03/13/2024
single use biliary balloon dilator OLYMPUS MEDICAL SYSTEMS CORP. k143303 02/27/2015
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
silverspeed hydrophilic guidewire, x-celerator hydrophilic exchange guidewire, x-pedion hydrophilic guidewire, mirage hy MICRO THERAPEUTICS, INC D/B/A: EV3 INC k124007 03/07/2013
silverlon antimicrobial wound contact negative pressure dressings, silverlon easy ag antimicrobial wound contact negativ ARGENTUM MEDICAL, LLC k141033 09/12/2014
silentcloud Aureliym GmBH k221125 01/04/2023
silent nite® sleep appliance with the glidewell hinge™ (snglhg) Prismatik Dentalcraft, Inc k233434 11/14/2023

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