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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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virtual slide system, olympus vs800 system OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP k111914 08/21/2012
ltm-labaroscopic surgical mesh LIFECELL CORP. k121289 08/03/2012
dimension alkaline phosphatase flex reagent cartridge, dimension alkaline phosphatase calibrator SIEMENS HEALTHCARE DIAGNOSTICS k121907 07/23/2012
flexstent biliary self-expanding stent system FLEXIBLE STENTING SOLUTIONS, INC. k121125 07/06/2012
able-x IM-ABLE LTD k120783 06/20/2012
lexus cervical intervertebral body fusion cage system L&K BIOMED CO., LTD k120840 05/24/2012
evolution colonic stent system COOK IRELAND LTD k113510 05/17/2012
rs safe black nitrile medical examination gloves powder or other proprietary name RIVERSTONE RESOURCES SDN. BHD. k112924 05/02/2012
bioplex 2200 apls igg and iga kit and calibrator and control sets Bio-Rad Laboratories k103834 03/30/2012
freestyle insulinx blood glucose monitoring system ABBOTT DIABETES CARE INC. k120568 03/29/2012

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