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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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harvey pv dry sterilizer, model # st127325; st127320; st127320-33 BARNSTEAD/THERMOLYNE CORP. k014174 02/22/2002
agiltrac .018 peripheral dilatation catheter GUIDANT CORP. k020161 02/22/2002
telescopic plate spacer thoracolumbar (tps-tl) spinal system, models 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189 INTERPORE CROSS INTL. k020204 02/21/2002
complete brand multi-purpose solution ALLERGAN, INC. k014202 02/20/2002
liberty blood glucose monitoring system POLYMEDICA PHARMACEUTICALS, U.S.A., INC.] k014167 02/19/2002
pacific hemostasis reference emulsion FISHER DIAGNOSTICS k013397 02/15/2002
synchron systems salicylate reagent and calibrator BECKMAN COULTER, INC. k014173 02/15/2002
promogran matrix wound dressing JOHNSON & JOHNSON MEDICAL, LTD. k014129 02/14/2002
flowguard device BIOSONIX LTD. k013803 02/13/2002
aos cannulated bone screw system ADVANCED ORTHOPAEDIC SOLUTIONS, INC. k014185 02/13/2002

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