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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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synthes (usa) sterile adjustable distal radius fixator (adrf) with 4.0mm/3.0mm self-drilling schanz screws SYNTHES (USA) k033411 11/26/2003
reflection constrained liner SMITH & NEPHEW, INC. k033442 11/26/2003
olympus lyophilized calibrator, models dr0070 and dr0071 OLYMPUS AMERICA, INC. k032665 11/21/2003
boston scientific 6f runway guide catheter BOSTON SCIENTIFIC CORP. k033441 11/21/2003
philips medical systems, m3012a- hemodynamic extension to the multi-measurement server PHILIPS MEDICAL SYSTEMS k033444 11/21/2003
epi-scan, model p 100 EDX EPI-SCAN, INC. k032935 11/20/2003
brightway brand latex examination glove-(powdered, sterile), containing 150 ugm or less of water extractable protein per BRIGHTWAY HOLDINGS SDN. BHD. k032938 11/20/2003
brightway brand latex examination glove-(powder free, sterile) containing 50 ugm or less of water extractable protein pe BRIGHTWAY HOLDINGS SDN. BHD. k032940 11/20/2003
lso pet/ct hirez and lso pet/ct 16 hirez CTI PET SYSTEMS, INC. k033431 11/20/2003
bruno electra-ride elite, model sre-2000 BRUNO INDEPENDENT LIVING AIDS, INC. k033438 11/20/2003

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