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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)
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Decision
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21.3 inch (53cm) monochrome digital mammography lcd monitor ms51i2, (mdl2123a) TOKOTU ELECTRIC CO., LTD. k081242 06/11/2008
3d accuitomo 150n J. Morita USA, INC. k201378 02/18/2021
3m attest rapid readout biological indicator 3M Company k200996 12/11/2020
4.5mm healix advance br anchor, with 2 or 3 strands of #2 permacord suture, 5.5mm healix advance br anchor, with 2 or 3 DEPUY MITEK, A JOHNSON & JOHNSON COMPANY k133794 02/04/2014
5cm tag applicator, 7cm tag applicator, 10 cm tag applicator, 5 cm tag applicator (10 pack), 7cm tag applicator (10 pack), 10cm tag applicator (10 pack), localizer surgical probe, localizer surgical probe (5 pack) Health Beacons, Inc. k181692 09/25/2018
absolute white light DR. FRESH, INC. k110888 01/12/2012
abt12 multi-purpose solution Bausch & Lomb Incorporated k202932 05/28/2021
access accutni reagent, access accutni calibrator, unicel dxi 800 access immunoassay system BECKMAN COULTER, INC. k121790 09/25/2013
accubind neo-tsh microwell elisa, model 3425-300 MONOBIND, INC. k063437 04/04/2008
accutip cover ACCUTOME, INC. k132549 04/23/2014

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