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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)
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Decision
Date
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malis 2000 bipolar electrosurgical system VALLEY FORGE SCIENTIFIC CORP. k050364 03/09/2005
bd onecath peripherally inserted central catheter, models 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 BECTON DICKINSON & CO. k051194 07/25/2005
modification to lncs oximetry sensors MASIMO CORPORATION k051212 07/12/2005
expanse vertebral body replacement device FLEXUSPINE, INC. k050997 10/07/2005
the notal vision preview preferential hyperacuity perimeter (preview php) NOTAL VISION, INC. k050350 04/29/2005
white knight masks (21 models, various colors with and without face shields) WHITE KNIGHT HEALTHCARE, INC. k001892 04/03/2001
compressor nebulizer system, model kn-9321 K-JUMP HEALTH CO., LTD. k051365 07/22/2005
ipf (immature platelet fraction) parameter on the sysmex model xe-2100 automated hematology analyzer SYSMEX AMERICA, INC. k051199 08/08/2005
echoview/shimasonic diagnostic ultrasound system, model sdu-1100 SHIMADZU MEDICAL SYSTEMS k050510 04/01/2005
jsz-multipurpose solution SZABOCSIK AND ASSOCIATES k050517 04/13/2005

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