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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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model 350g gas conserver INSPIRED TECHNOLOGIES, INC. k090421 05/29/2009
modification to gyrus acmi invisio icn, models icn-0564 and icn-0565 GYRUS ACMI, INC. k090814 04/20/2009
everon EARLYSENSE LTD. k082465 03/25/2009
energist ultraplus variable pulsed light (vpl) system ENERGIST, LTD. k082825 02/06/2009
medilas d family lasers, including medilas d litebeam, litebeam +, urobeam, multibeam, flexipulse and magnapulse DORNIER MEDTECH AMERICA, INC. k083258 01/30/2009
virtuosaph (tm) endoscopic vein harvesting disposable system, model mcvs550 TERUMO CARDIOVASCULAR SYSTEMS CORP. k083194 01/16/2009
bioclean chemo emerald powder free nitrile examination gloves NITRITEX (M) SDN. BHD. k081972 12/11/2008
bionet bm3plus patient monitor BIONET CO., LTD. k082008 12/11/2008
twinlotus and shields natural rubber latex condom DAILIAN LATEX COMPANY, LTD. k081413 10/24/2008
monopoly pedicle screw system SIGNUS MEDICAL LLC. k081108 07/14/2008

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