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U.S. Department of Health and Human Services

510(K) Premarket Notification

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tewa cj-type, pj-type, cb-type and pb-type acupuncture needles for single use MAANSHAN MEDICAL INSTRUMENTS CO., LTD. k052846 12/22/2005
pana-spray NSK AMERICA CORP. k052700 12/20/2005
theraknit garment electrode NEUROTRON MEDICAL k053214 12/20/2005
medtronic m2 magnet adjustment tool MEDTRONIC NEUROSURGERY k052386 12/16/2005
igi-system DENX ADVANCED DENTAL SYSTEMS k052840 12/16/2005
b-care powdered latex examination gloves B-CARE INDUSTRIES CO., LTD. k052845 12/16/2005
stageone disposable cement spacer mold for temporary hip prosthesis with reinforcement stem BIOMET, INC. k052990 12/16/2005
ge voluson i GENERAL ELECTRIC CO. k053435 12/16/2005
i-stat creatine kinase mb (ck-mb) I-STAT CORPORATION k051433 12/15/2005
troponin i ultra assay and calibrator for the advia ims system BAYER HEALTHCARE, LLC k052503 12/14/2005

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