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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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modification to: satellite spinal system MEDTRONIC SOFAMOR DANEK k060415 01/05/2007
easygluco, model igm-0002 g2 US DIAGNOSTICS, INC. k061431 01/12/2007
cf-1 CANON, INC. k063717 01/23/2007
vortex ct port access system and lifeguard safety infusion set RITA MEDICAL SYSTEMS, INC. k062414 02/01/2007
c.t.m. mobility scooter, model hs-310 C.T.M. HOMECARE PRODUCT, INC. k070025 02/01/2007
roche total mycophenolic acid assay, calibrators and controls Roche Diagnostics k063520 02/16/2007
osteofix bone void filler CALCITEC, INC k070220 04/12/2007
discyphor catheter system, model d01a; discyphor introducer needle, model d01b KYPHON, INC. k063071 04/13/2007
euroimmun ana ifa: hep-20-10 EUROIMMUN US LLC k070763 05/22/2007
x3c 1600 digital radiographic system IMAGING DYNAMICS COMPANY LTD. k071403 06/11/2007

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