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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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nexgen complete knee solution rotatng hinge knee ZIMMER, INC. k013385 01/09/2002
elite monophase ZHERMACK S.P.A. k022653 10/28/2002
84 channel eeg XLTEK k014146 01/14/2002
80 channel eeg XLTEK k014147 01/14/2002
wu's 4-wheeled neo scooter, wt-l4 WU'S TECH CO., LTD. k013763 07/30/2002
wu's 3-wheeled neo scooter, wt-m3 WU'S TECH CO., LTD. k014119 07/25/2002
dermagrip powder free latex examination gloves with aloe vera protein content labeling claim (50 micrograms or less) WRP SPECIALTY PRODUCTS SDN. BHD. k012876 10/01/2001
advance unicondylar knee system WRIGHT MEDICAL TECHNOLOGY, INC. k014171 03/15/2002
endoscopic camera tc804/c4 WORLD OF MEDICINE LEMKE GMBH k014158 03/14/2002
reliefband nst device, model wb-2l, wb-6l, wb-rl WOODSIDE BIOMEDICAL, INC. k994387 03/16/2000

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