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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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mammomark, mammomark mr and cormark biopsy site identifiers ETHICON ENDO-SUGERY, LLC k082278 12/16/2008
healthline medicator / redineb aerosol drug delivery system MEDI NUCLEAR CORP., INC. k082541 11/26/2008
stimpro, models sp22050, sp20100, spp19050, spp19100, spp19150, spc19050, spc19100, spc19150, spc18050,spc18100,spc18150 LIFE-TECH, INC. k082772 02/09/2009
rad source x-ray blood irradiator, model rs-3400 RAD SOURCE TECHNOLOGIES, INC. k082921 02/17/2009
md21m 21.3 diagnostic imaging lcd monitor, model l218tk NEC DISPLAY SOLUTIONS, LTD. k083332 01/09/2009
bpz02 multipurpose solution BAUSCH & LOMB, INC. k083757 11/18/2009
bci ww1021 pc application SMITHS MEDICAL PM, INC. k090205 04/28/2009
rotaflow centrifugal pump with softline coating, model bo-rf-32 (usa) MAQUET CARDIOPULMONARY AG k090515 12/18/2009
cfi ultrasound probe drape CONTOUR FABRICATORS, INC. k090773 09/18/2009
pinnacle3 smartarc PHILIPS MEDICAL SYSTEMS, INC. k090808 04/03/2009

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