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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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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
compress distal femoral replacement BIOMET, INC. k031804 12/18/2003
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
keeler wide angle ophthalmoscope model 1130-p-5004 KEELER INSTRUMENTS, INC. k032087 11/26/2003
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
h/s catheter set CATHETER RESEARCH, INC. k032835 12/11/2003
profeel powder free, ploymer coated polyisoprene surgical gloves, sterile WRP ASIA PACIFIC SDN. BHD. k032942 12/17/2003
inion cps baby 1.5 bioabsorbable system INION LTD. k033194 10/30/2003
hemaderm MEDAFOR, INC. k033666 12/17/2003

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