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U.S. Department of Health and Human Services

510(K) Premarket Notification

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powder free clear synthetic vinyl examination gloves, small, medium, large, x-large SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. k043159 12/20/2004
dream cleanse s scaler, dream compact s scaler AMERICAN GREEN DENT. MFG, INC. k033044 12/21/2004
m2a/c2a acetabular system BIOMET, INC. k042841 12/21/2004
titan high resolution ultrasound system and sonosite ultrasound system SONOSITE,INC. k043452 12/21/2004
sa8000 se diagnostic ultrasound system MEDISON CO., LTD. k043455 12/21/2004
the reliance pi process indicator, model d5116 STERIS Corporation k043482 12/21/2004
quantex myoglobin INSTRUMENTATION LABORATORY CO. k042982 12/22/2004
ascensia brio blood glucose monitoring system BAYER HEALTHCARE, LLC k043158 12/22/2004
ascensia elite diabetes care system BAYER HEALTHCARE, LLC k043311 12/22/2004
lifestent nt35 biliary stent system EDWARDS LIFESCIENCES, LLC. k042985 12/23/2004

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