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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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relyx luting plus automix 3M ESPE DENTAL PRODUCTS k111185 05/05/2011
loqteq proximal humerus plate 3.5, short loqteq proximal humerus plate 3.5, long AAP IMPLANTATE AG k121495 12/07/2012
microhybrid 11 AB ARDENT k022971 11/25/2002
freestyle libre 3 continuous glucose monitoring system; freestyle libre 2 flash glucose monitoring system Abbott Diabetes Care Inc. k223435 04/13/2023
gem hemochron 100 system, gem hemochron 100 activated clotting time plus test (act+), gem hemochron 100 low range activated clotting time test (act-lr), directcheck act+ whole blood control, level 1 and level 2, directcheck act-lr whole blood control, level 1 and level 2 Accriva Diagnostics, Inc. k202101 12/29/2021
vascucel Admedus Regen Pty Ltd k162579 10/14/2016
hi-torque middle support .012 guide wire with hydrocoat hydrophilic coating ADVANCED CARDIOVASCULAR SYSTEMS, INC. k012534 01/24/2002
powder free blude nitrile patient examination glove, non-sterile ADVANCED HEALTH PRODUCTS, LOT 60 & 61 k132354 06/30/2014
dailies aquacomfort plus, dailies aquacomfort plus toric, dacp multifocal, focus dailies, focus dailies toric, focus dailies progressives ALCON LABORATORIES, INC. k161391 11/30/2016
focus dailies / focus dailies toric / focus dailies progressives, dailies aquacomfort plus (dacp) / dacp toric / dacp multifocal, freshlook one-day, dailies total 1 / dailies total 1 multifocal Alcon Laboratories, Inc. k180669 04/27/2018

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