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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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510(K)
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Decision
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nitrile exam gloves, powder-free, color blue SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. k001128 05/23/2000
non-sterile powder free bubble-gum scented latex examination glove with protein content labeling claim (50 micrograms or SGMP CO., LTD. k002175 07/31/2000
non-sterile powder free pineapple scented latex examination gloves with protein content labeling claim (50 micrograms le SGMP CO., LTD. k002176 07/31/2000
novabone-bioglass bone graft particulate U.S. BIOMATERIALS CORP. k000149 02/07/2000
numalink NUMA, INC. k002724 11/17/2000
nupro prophylaxis paste with fluoride and triclosan DENTSPLY INTL. k000169 03/24/2000
nuzone nitrile surgical gloves powder free TERANG NUSA SDN BHD k000179 05/15/2000
nuzone nitrile surgical gloves, powdered, green TERANG NUSA SDN BHD k000178 05/23/2000
nylon, nonabsorbable surgical sutures usp CP MEDICAL k001173 06/23/2000
o-perm 30 OPTICAL POLYMER RESEARCH, INC. k002703 11/21/2000

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