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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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plastic port implantable venous access system SIMS DELTEC, INC. k994216 01/27/2000
polymer coated powder free nitrile examination gloves, blue FLEXITECH SDN. BHD. k994416 02/03/2000
polymer coated, powder free, latex examination gloves with protein content labeling claim (50 micrograms or less) FLEXITECH SDN. BHD. k994354 01/31/2000
porges ureteral catheters, models acn6xx, acn5xx, ac5b, ac5c07, acp5xx, acp2xx, acp3xx, acp4xx, acp6xx PORGES S.A. k021856 10/17/2002
positron emission tomography (pet) and computed tomography (ct) system, positron emission tomography (pet) and computed tomography (ct) system NEUSOFT MEDICAL SYSTEMS CO., LTD. k151403 11/02/2015
powder free clear synthetic vinyl examination gloves, small, medium, large, x-large SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. k043159 12/20/2004
powder free latex examination patient gloves PURNABINA SDN BHD k994420 09/18/2000
powder free vinyl patient examination gloves, colored (yellow) TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD k100058 03/05/2010
powder-free vinyl patient examination gloves SHIJIAZHUANG HYLAND PLASTIC CO., LTD k102611 10/21/2010
powdered (blue) nitrile patient examination gloves SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT k021506 06/06/2002

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