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U.S. Department of Health and Human Services

510(K) Premarket Notification

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tgdc-01 pra TRUEVISION INSTRUMENTS k021937 10/11/2002
navigus manual disposable microdrive with digital display, models mi-1000 & mi-1010 IMAGE-GUIDED NEUROLOGICS, INC. k022100 09/25/2002
bd directigen ez rsv kit BECTON DICKINSON & CO. k022133 12/10/2002
surgassist right angle linear cutter dlu 30mm, 45mm & 60mm - vascular with reloads, models ralc30v, ralc45v & ralc60v POWER MEDICAL INTERVENTIONS, INC. k022313 12/09/2002
framelock; framelock accessories MEDTRONIC XOMED, INC. k022370 10/18/2002
medcomp repair kit, model aspcrpk MEDCOMP k022570 10/31/2002
trident screw hole plug and trident bone spike HOWMEDICA OSTEONICS CORP. k022799 11/21/2002
vita in-ceram yz cubes for cerec VIDENT k022996 10/09/2002
bptru vital signs monitor, model bpm-300, & bptru portable automated non-invasive blood pressure and temperature monitor VSM MEDTECH LTD. k023078 03/21/2003
cedia cyclosporine plus assay MICROGENICS CORP. k023208 10/24/2002

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