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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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microscan microstrep plus panel-meropenem DADE MICROSCAN, INC. k020938 06/03/2002
spectral's 2 in 1 (tni-myo) SPECTRAL DIAGNOSTICS, INC. k020950 05/24/2002
h/s catheter set (5f), model 61-5005; h/s catheter set (7f), model 61-5007 ACKRAD LABORATORIES k020951 04/16/2002
surx rf system SURX, INC. k020952 05/30/2002
h/s procedure tray (5f), h/s procedure tray (7f), h/s elliptosphere procedure tray & multipurpose procedure tray ACKRAD LABORATORIES k020954 04/24/2002
nicolet electrocautery detector NICOLET BIOMEDICAL, INC. k020955 04/17/2002
lifeport, kidney perfusion transporter (ktr) ORGAN RECOVERY SYSTEMS, INC. k021362 07/31/2003
endovascular guide wire STEREOTAXIS, INC. k021363 11/27/2002
modification to entec plasma wands ARTHROCARE CORP. k021364 05/30/2002
mac-lab/cardiolab ep/combolab GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN k021366 07/03/2002

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