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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
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ceram-prime S & C Polymer GmbH k002502 11/08/2000
shiley tracheosoft xlt extended length tracheostomy tube and disposable inner cannula Mallinckrodt, Inc. k003315 11/08/2000
acme spine system - series 6000, 7000, monoaxial and polyaxial screw system Acme Spine, LLC k001044 11/03/2000
mercury medical hyperinflation bag system, model 83-900-0149 Mercury Medical k001714 11/03/2000
novalis (shaped beam surgery system) Brainlab AG k002509 11/03/2000
microtainer brand sodium fluoride/edta tube with microgard closure, model 365992 Becton Dickinson Vacutainer Systems k002456 11/02/2000
power 5000 general purpose coil Usa Instruments, Inc. k002483 10/25/2000
simplicity soft infusion set Sterling Medivations, Inc. k002492 10/24/2000
radionics rf disc catheter electrode system Radionics, Inc. k001741 10/23/2000
x-posure system version 2 rad Pronosco A/S k002500 10/23/2000

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