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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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sonoace 600 diagnostic ultrasound system MEDISON AMERICA, INC. k000030 01/19/2000
alkaline phosphatase liquid reagent-kinetic, models a504-150 and a504-500h TECO DIAGNOSTICS k000067 01/20/2000
camlog cylinder implant system ALTATEC BIOTECHNOLOGIES k000065 01/28/2000
sealouette fibrin sealant extended droplet applicator, model te-1 BIOSURGICAL CORP. k000048 01/31/2000
arthrocare controller, arthrocare cable, footswitch, powercord, arthrowands and spinewands ARTHROCARE CORP. k000044 02/01/2000
modification to isobar spinal system ENCORE ORTHOPEDICS, INC. k000020 02/03/2000
depuy contour unicompartmental knee prosthesis DEPUY ORTHOPAEDICS, INC. k000172 02/03/2000
entec reflex wand 55, model e4055-00 ARTHROCARE CORP. k000036 02/04/2000
arthrocare controller, arthrocare cable, footswitch, powercord, plasma scalpel gs, turbovac gs ARTHROCARE CORP. k000074 02/04/2000
x-ray monoblock, monoblock xrs-60-330 DYNARAD CORP. k000052 02/10/2000

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