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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
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otomimix WALTER LORENZ SURGICAL, INC. k042516 11/08/2004
spatula, cervical, cytological, model 22-9107 MEDICAL ACTION INDUSTRIES, INC. k042527 11/08/2004
submarine plus percutaneous transluminal angioplasty (pta) catheter, model suvxxxxxxxxx INVATEC INNOVATIVE TECHNOLOGIES k042537 11/08/2004
minineph human rheumatoid factor kit THE BINDING SITE k041891 11/05/2004
liquichek reticulocyte control (a) BIO-RAD k042836 11/05/2004
arthrex tenodesis screw family ARTHREX, INC. k041356 11/04/2004
ge signa excite 1.5t 6 channel phased array flex coil, ge signa excite 3.0t 6 channel phased array flex coil GE MEDICAL SYSTEMS, INC. k042844 11/03/2004
aquify lens comfort drops CIBA VISION CORPORATION k042176 11/03/2004
liquichek elevated crp control BIO-RAD k042837 11/02/2004
savedent blue DENFOTEX LIGHT SYSTEMS LTD k042196 11/01/2004

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