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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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Decision
Date
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integra radionics xknife rt 4 INTEGRA RADIONICS, INC. k061893 07/25/2006
integra selector ultrasonic surgical aspirator system with bone tip INTEGRA RADIONICS, INC. k071669 08/17/2007
intellifat disposable adipose tissue harvesting and transfer kit, intellifat body on demand (bod) kit Millennium Medical Technologies Inc (DBA Cellmyx) k210528 03/16/2022
intraject GENERAL MEDICAL ENGINEERING CORP. k802332 12/22/1980
intraocular lens MILTON ROY CO. ANALYTICAL k770728 04/28/1977
intrelief EasyMed Instruments Co., Ltd. k211263 12/30/2021
iridium 192 wires & pins CIS RADIOPHARMACEUTICALS, INC. k771878 10/27/1977
irts thermal imaging probe (tip);irts patient monitoring unit (pmu);irts patient interface unit (piu) SECURUS,INC k152402 03/04/2016
isoelasticu REMI SCIENCES, INC. k081025 11/21/2008
ivas 2-10mm (10 gauge) balloon catheter, ivas 2-15 mm(10 gauge)0705-115-500, ivas 3-10mm(8 gauge)balloon catheter, ivas STRYKER INSTRUMENTS, INSTRUMENTS DIV. k093419 03/18/2010

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