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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
Date
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sodium test kit and eletrolyte cal 1 and 2 RANDOX LABORATORIES, LTD. k043268 02/15/2005
stratus cs acute care nt-probnp testpak, pbnp calpak calibrator, pbnp dilpak diluent DADE BEHRING, INC. k043476 02/15/2005
modification to acuson cv70 cardiovascular system SIEMENS MEDICAL SOLUTIONS USA INC. k050240 02/15/2005
vitek 2 compact BIOMERIEUX, INC. k050002 02/17/2005
infinity kappa xlt Draeger Medical Systems, Inc. k042904 02/18/2005
liberty system INOVISE MEDICAL, INC. k043074 02/22/2005
quadrant retractor system MEDTRONIC SOFAMOR DANEK k043602 02/23/2005
endoassist ARMSTRONG HEALTHCARE LIMITED k043284 02/25/2005
moments menopause check, model 9113 PHAMATECH INC. k043599 02/25/2005
philips heartstart frx defibrillator, model 861304 PHILIPS MEDICAL SYSTEMS k050004 02/25/2005

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