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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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cyto-stat tetrachrome cd45-fit/cd4-pe/cd3-pc5 monoclonal antibody reagent, cyto-stat tetrachrom cd45-fitc/cd56-pe/cd19-a BECKMAN COULTER, INC. k030408 03/04/2003
hl888ha HEALTH & LIFE CO., LTD. k030498 04/11/2003
powdered vinyl exam gloves, white HEYUAN HONGLI INDUSTRIES, INC. k030997 05/02/2003
aquasoft (ocufilcon d) daily wear contact lens clear and visibility tint, with uv blocker CLEARLAB PTE LTD. k030748 05/14/2003
cook vascular serpenta coronary sinus introducer system COOK VASCULAR, INC. k023937 05/27/2003
modification to iskd (intramedullary skeletal kinetic distractor) ORTHOFIX, INC. k031219 05/28/2003
the philips intellivue mp60, mp70, and mp90 patient monitors, release a.20 PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH k031481 05/29/2003
glovetex powder free latex examination gloves, blue, non-sterile contains 50 mcgin or less of total water extractable pr PT. WRP BUANA MULTICORPORA k032007 07/28/2003
toshiba excelart vantage xgv/agv mri diagnostic system, models mrt-1503/p3 and mrt-1503/p2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. k032490 08/21/2003
inion cps baby 1.5 bioabsorbable system INION LTD. k033194 10/30/2003

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