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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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gemini 16 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. k032036 07/11/2003
kamar annulus dilator + sizer; garrett, cooley, and debakey vessel dilators GEISTER MEDIZINTECHNIK GMBH k030788 07/12/2003
ultraflex precision colonic stent BOSTON SCIENTIFIC CORP. k030769 07/14/2003
vaxcel with pasv port, model 45-213 BOSTON SCIENTIFIC CORP. k032008 07/14/2003
mayo clinic bc-10 1.5t MAYO MEDICAL VENTURES k031119 07/15/2003
philips compurecord peri-operative information system software PHILIPS MEDICAL SYSTEMS k030939 07/15/2003
estylus electric motor system DENTSPLY INTL. k031145 07/15/2003
ecn electronic video cystonephroscope ACMI CORPORATION k030960 07/16/2003
mentor obtape trans-obturator tape MENTOR CORP. k031767 07/17/2003
phillips omnidiagnost eleva PHILIPS MEDICAL SYSTEMS, INC. k032046 07/17/2003

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