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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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coolief radiofrequency generator (crg) system Avanos Medical, Inc. k192491 02/21/2020
kdr au-ddr system advanced u-arm with dynamic digital radiography, kdr au system advanced u-arm with static digital radiography Konica Minolta Healthcare Americas, Inc k193225 01/15/2020
air next NuvoAir AB k183089 01/02/2020
single use balloon dilator v (with knife) Olympus Medical Systems Corp. k193039 12/17/2019
diode laser 808nm Beijing Superlaser Technology Co., Ltd. k192516 12/10/2019
hair growth system Kunshan Bella Optical technology Co., Ltd. k191754 11/22/2019
medicad web mediCAD Hectec GmbH k183412 10/31/2019
aptus wrist spanning plates 2.5 Medartis AG k191848 09/30/2019
acist cvi1 contrast delivery system, a1000 syringe kit, a1000v syringe kit, bt2000 manifold kit, bt2000 manifold kit, angiotoiuch hand controller kit ACIST Medical Systems, Inc. k191060 07/18/2019
intra-operative positioning system; simple curve catheter, reverse curve catheter ; angled tip guidewire ; tracking pad ; guidewire handle Centerline Biomedical, Inc. k190106 06/24/2019

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