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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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digital ultrasonic diagnostic imaging system, model dp-6900 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD k090912 04/15/2009
versafit cup double mobility system MEDACTA INTERNATIONAL, SA k083116 04/07/2009
pronto v3 extraction center, model 5003, pronto lp extraction catheter, model 5010, skyway rx support catheter, VASCULAR SOLUTIONS, INC. k083784 03/30/2009
myoscience cryo-touch MYOSCIENCE INC k083493 03/20/2009
fukuda denshi dynascope model ds-7000 series patient monitor, model ds-7000//7000m/7210/7210m FUKUDA DENSHI USA, INC. k083697 03/19/2009
dimension vista beta 2 microglobulin, dimension vista protein 1 calibrator, dimension vista protein 1 control m SIEMENS HEALTHCARE DIAGNOSTICS k083463 03/13/2009
advia chemistry cystatin c reagent, advia chemistry cystatin c calibrator, models p/n 04851534, p/n 10376487 SIEMENS HEALTHCARE DIAGNOSTICS k083906 03/11/2009
semi-fully automatic electronic blood pressure monitor, models: kd-322,kd-622,kd-575,kd-525e,kd-593,kd-595,kd-596,kd-598 ANDON HEALTH CO.,LTD k083395 02/27/2009
contec pocket fetal doppler CONTEC MEDICAL SYSTEM CO., LTD. k082480 02/25/2009
atomlab 400 and atomlab 500 dose calibrators, models 086-330, -331, -332, -335 and -336 BIODEX MEDICAL SYSTEMS, INC. k090296 02/19/2009

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