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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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lerado, cosco Lerado Oversea Ltd. Twn Branch (Bvi) k050290 02/18/2005
modification to: pneuton ventilator Airon Corporation k043085 12/20/2004
heart rate turbulence analysis technologies Ge Medical Syst. Information Technologies k042148 12/03/2004
quikread crp calibrator set Orion Diagnostica, OY k042625 11/18/2004
synchron systems phosphorus (phs) reagent Beckman Coulter, Inc. k041643 08/18/2004
raichem bun rate reagent (liquid) Hemagen Diagnostics, Inc. k041051 06/30/2004
philips anesthesia gas monitor, model m1026b Philips Medizin Systeme Boeblingen GmbH k040917 04/29/2004
precision link diabetes data management system Abbott Laboratories k040628 03/25/2004
bird tbird vela ventilator Bird Products Corp. k032451 03/17/2004
integral hemodialysis catheter Arrow Int'L. k040260 03/05/2004

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