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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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tissue marker ADVANCED UROSCIENCE, INC. k001807 05/03/2001
doro headrest system PRO-MED INSTRUMENTS GMBH k001808 08/04/2000
urisite urine collection kit for microalbumin/creatinine testing FLEXSITE DIAGNOSTICS, INC. k001810 08/14/2000
neu-ion hemodialyis water treatment system NEU-ION, INC. k001811 10/25/2000
pvp-polyvinylpyrrolidone reagent, model cat#2210 INVITROCARE, INC. k001967 08/14/2000
gt2 fusion guide wire, model ntlhlj180,ntlhls180, ntlhlj300, ntlhls300 MEDTRONIC VASCULAR k001969 08/16/2000
jet 1 powered wheelchair PRIDE MOBILITY PRODUCTS CORP. k001970 09/26/2000
hemodialysis tubing sets OFI BIOMEDICA S.P.A. k001971 05/24/2001
argus system-continuous expert care network VISICU, INC. k001972 10/27/2000
ez-on condom MAYER LABORATORIES k001974 10/24/2001

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