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U.S. Department of Health and Human Services

510(K) Premarket Notification

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ipl hair removal device, model(s): ui04a, ui04b, ui04c Shenzhen Ulike Smart Electronics Co.,Ltd k221002 06/01/2022
inverness medical early pregnancy test CAMBRIDGE DIAGNOSTICS IRELAND, LTD. k013907 12/18/2001
intracept intraosseous nerve ablation system (rf probe), intracept intraosseous nerve ablation system (access instruments), relievant rf generator Relievant Medsystems k190504 05/03/2019
insuflow co2ionshield LEXION MEDICAL, LLC. k090879 07/23/2009
infx-8000v with wireless footswitch TOSHIBA MEDICAL SYSTEMS CORPORATION k143225 01/09/2015
infpump infiltration pump CAROLINA MEDICAL, INC. k050324 04/27/2005
impact, universal single-limb, ventilator circuit, model 820-0099-00 IMPACT INSTRUMENTATION, INC. k022062 05/06/2003
imorgon ultrasound pacs solutions SEA RIDGE SOFTWARE, INC. k050736 05/05/2005
immunalysis eddp specific urine enzyme immunoassay, immunalysis eddp urine calibrators, immunalysis eddp urine control sets Immunalysis Corporation k151395 07/24/2015
ilab polaris multi-modality guidance system Boston Scientific k201178 05/29/2020

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