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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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somatom respiratory gating SIEMENS MEDICAL SOLUTIONS USA, INC. k043086 12/23/2004
easylistener 2 fm, radium fm and vocalight infrared sound field systems PHONIC EAR, INC. k043090 12/23/2004
datex-ohmeda s/5tm fm with l-ficu04 and l-ficu04a software and n-fcrec module DATEX-OHMEDA k043276 12/23/2004
herbert ulnar head prosthesis system STUCKENBROCK MEDIZINTECHNIK GMBH k042902 12/27/2004
cementek lv TEKNIMED SA k042911 12/27/2004
disposable non-adhesive spo2 sensors ELEKON INDUSTRIES U.S.A., INC. k042705 12/29/2004
fidji-vertebral body replacement type 5 SPINE NEXT AMERICA CORPORATION k042713 12/29/2004
fidji-vertebral body replacement type 1, 2, 3 and 4 SPINE NEXT AMERICA CORPORATION k042714 12/29/2004
modification to: zilver 635 biliary stent COOK, INC. k043481 12/29/2004
medtronic snt stealthstation axiem imageless knee module MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES k043088 01/05/2005

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