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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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powder-free latex examination gloves with protein label claim contains 50 micrograms or less of total water label claim PROTECTION GLOVES SDN. BHD. k000667 04/28/2000
powder-free non-vhlorinated polymer coated latex examination gloves contains 100 micrograms or less of total water extra PROTECTION GLOVES SDN. BHD. k000668 04/28/2000
powdered latex exam gloves, pink, with/without strawberry scent, protein labeling SGMP CO., LTD. k000671 03/29/2000
ppcid- pneumatic peripheral circulation improvement (footrest) device AHAVA STEIN k000655 03/26/2001
pq1 ULTRADENT PRODUCTS, INC. k000189 05/11/2000
precision dosimetry electrometer, model 1010 or 206 SUN NUCLEAR CORP. k002444 10/18/2000
prolite pulsed light system MEDICAL BIO CARE SWEDEN AB k000929 10/17/2000
proton vision VARIAN ASSOC., INC. k000922 05/24/2000
pst electrosurgical generator, model 2150, pst bipolar forceps, model ebf 1228 PST, INC. k003249 12/12/2000
qps/bpgs/moco processing applications for entegra workstation GE MEDICAL SYSTEMS F.I. HAIFA k003264 12/21/2000

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