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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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Applicant
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510(K)
Number
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Decision
Date
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gii spinal fixation system, gii-ti-poly axial screw Co-Ligne AG k083567 09/14/2009
ghajar intraventricular catheter guide Sparta Instrument Corp. k854475 02/20/1986
gentamicin sulfate solution (50mg gentamicin) Flow Laboratories, Inc. k861823 05/20/1986
gauze bandage roll Cal West Trading Co. k914842 12/04/1991
gas chromatograph 5890a Hewlett-Packard Co. k832962 10/28/1983
full automatic (nibp) blood pressure monitor, model hl168kb Health & Life Co., Ltd. k092163 11/16/2009
ft model table w/electric hi lo option e Pro Med Mfg., Inc. k925563 05/26/1993
fst cath ud-dual dual pressure catheter Fiberoptic Sensor Technlogies, Inc. k926088 06/18/1993
fresenius a2008 hemodialysis machine expansion mod Seratronics, Inc. k844750 02/15/1985
fox post nasal balloon catheter Inmed Corp. k841040 08/17/1984

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