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U.S. Department of Health and Human Services

510(K) Premarket Notification

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medtronic minimed sof-site infusion set, models mmt-358s6, mmt-358m6, mmt-358l6, mmt-358s9, mmt-358m9, and mmt-358l9 AVAIL MEDICAL PRODUCTS, INC. k030137 02/19/2003
technos mp, model au6 BIOSOUND ESAOTE, INC. k023255 02/11/2003
dermagrip-x powder free latex examination gloves with skin-care ingredients (vitamin a, vitamin b, oc-lipoic acid, eucal WRP ASIA PACIFIC SDN. BHD. k023490 01/16/2003
propeller head small cannulated screw system BIOMET ORTHOPEDICS, INC. k024086 01/09/2003
modification to mediprime ALGOTEC SYSTEMS, LTD. k023936 12/20/2002
imagechecker-ct workstation R2 TECHNOLOGY, INC. k023003 11/20/2002
monarc sling system AMERICAN MEDICAL SYSTEMS, INC. k023516 11/19/2002
digital electrical muscle stimulator, model ev-807 digital ems EVERYWAY MEDICAL INSTRUMENTS CO., LTD. k020750 10/31/2002
xenon fiberoptic light source, model 1300 xsbp ISOLUX AMERICA k022384 10/18/2002
transfer companion hr 3000 manual wheelchair FOREVER YOUNG ENT. CO., LTD. k022699 09/13/2002

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