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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
Number
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Decision
Date
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immulite 2000 3gallergy specific ige assay kit, model l2kun6 Siemens Medical Solutions Diagnostics k100910 05/11/2011
atama system Monteris Medical, Inc. k110411 04/08/2011
powerpicc sv catheters C.R. Bard, Inc. k102159 11/17/2010
eco-s Vericom Co., Ltd. k103121 10/26/2010
zip'r mantis powered wheelchair Global Fabtech Wheelchair (Shanghai) Co., Ltd. k102355 10/04/2010
hi vision preirus doagnostic ultrasound scanner model hi vision preirus Hitachi Medical Systems America, Inc. k093466 06/17/2010
oral/enteral syringes Philips Children'S Medical Ventures k100099 06/14/2010
champions implants gmbh mimi 1-piece precision implant, model 1000 up to 6000 Champions Implants GmbH k091182 01/07/2010
full automatic (nibp) blood pressure monitor, model hl168kb Health & Life Co., Ltd. k092163 11/16/2009
powder free latex examination gloves, blue, tested for use with chemotherapy drugs Gx Corporation Sdn Bhd k091643 11/02/2009

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