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U.S. Department of Health and Human Services

510(K) Premarket Notification

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xidf-aws801, angio workstation, v5.31 TOSHIBA MEDICAL SYSTEMS CORPORATION k141541 09/08/2014
unimicro suction irriation tubing set UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. k141592 08/04/2014
telefelx isis hvt tracheal tube, cuffed with subglottic secretion suction port; with stylet Teleflex Medical, Inc. k141939 11/24/2014
polychloroprene powder-free surgical glove (white) tested for use with chemotherapy drugs; polychloroprene powder-free surgical glove (green) tested for use with chemotherapy drugs PT MEDISAFE TECHNOLOGIES k142190 07/14/2015
sensititre hp mic susceptibility plate with tedizolid (0.002-4 mcg/ml) THERMO FISHER SCIENTIFIC k142338 03/02/2015
flexcath select steerable sheath (10 french) Medtronic CryoCath LP k142684 11/06/2014
xuanye powder free vinyl patient examination gloves, clear (non-colored) Xuanhua Metallurgical Industry CO., LTD k142771 12/22/2014
adiva centaur prolactin master curve material (mcm), adiva centaur cortisol master curve material (mcm) SIEMENS HEALTHCARE DIAGNOSTICS, INC. k143194 12/05/2014
infx-8000v with wireless footswitch TOSHIBA MEDICAL SYSTEMS CORPORATION k143225 01/09/2015
stryker mis attachments and cutting accessories STRYKER CORPORATION k143540 05/01/2015

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