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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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full automatic (nibp) blood pressure monitor, model hl168jt Health & Life Co., Ltd. k050711 04/07/2005
powder free nitrile examination gloves (white, blue, and purple color) Platinum Glove Industries Sdn. Bhd. k051318 06/17/2005
t-plate anterior fixation system Esm Technologies k051764 07/13/2005
mee-1000a neuromaster Nihon Kohden America, Inc. k051178 08/17/2005
i-port Patton Medical Devices k052389 09/09/2005
vitros chemistry products dtibc reagent Ortho-Clinical Diagnostics, Inc. k052867 12/23/2005
bp pro blood pressure monitor Card Guard Scientific Survival , Ltd. k053395 12/23/2005
the phillips, model mp20,mp30,mp40,mp50,mp60,mp70,mp80,and mp90 intellivue patient monitors Philips Medizin Systeme Boeblingen GmbH k060221 02/17/2006
migwang comfort 38 (polymacon) spherical and toric soft contact lens for daily wear (clear, tinted and cosmetic) Mi Gwang Contact Lens Co., Ltd. k051477 03/10/2006
robertsite stopcock Halkey-Roberts Corp. k061143 05/10/2006

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