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U.S. Department of Health and Human Services

510(K) Premarket Notification

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d2rs_at digital dynamic remote system STEPHANIX RADIOLOGICAL SOLUTIONS k150306 10/10/2015
eclipse treatment planning system VARIAN MEDICAL SYSTEMS, INC. k152393 09/18/2015
rapidfret oral fluid assay for cocaine, rapidfret oral fluid cocaine calibrator set, rapidfret oral fluid cocaine control set BIOPHOR DIAGNOSTICS, INC. k142129 07/24/2015
disposable blood pressure cuff, reusable blood pressure cuff XUZHOU MAICUFF TECHNOLOGY CO.,LTD. k151290 06/30/2015
philips intellivue mp2/mp5/mpsc patient monitors, philips intellivue x1 and x2 multi-msrmt-modules for use with intellivue patient monitors PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH k150975 06/25/2015
spec model m16 Source Production and Equipment Co.,Inc. k150895 06/19/2015
powder free nitrile gloves (white), powder free nitrile gloves (cobalt blue), powder free nitrile gloves (black), powder free nitrile gloves (ice blue) HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD k150340 06/18/2015
jusha-m23c lcd monitor NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD k151238 06/12/2015
apex-dl spine system SPINECRAFT LLC k143683 05/22/2015
st. jude medical mediguide enabled livewire steerable electroohysiology catheter, livewire electrophysiology catheter St. Jude Medical k150631 04/01/2015

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