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U.S. Department of Health and Human Services

510(K) Premarket Notification

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191 to 200 of 500 Results *
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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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modified m-iv mammography system LORAD, A HOLOGIC CO. k011987 07/11/2001
access sequestration system INTERPORE CROSS INTL. k012406 03/26/2002
sterile latex examination gloves (powdered) with protein claim less than 100ug/g SMART GLOVE CORP. SDN BHD k012856 11/16/2001
non-sterile powder free purple latex examination glove with blueberry scented and protein content claim (50 micrograms o SGMP CO., LTD. k012857 09/21/2001
nu-spec d SOL WEISS MD INC k012859 10/26/2001
powder-free latex exam gloves with chocolate scenting and protein labeling claim (<50ug/g) SGMP CO., LTD. k012860 09/21/2001
vascupuncture access wire NEO METRICS, INC. k012861 02/05/2002
non-sterile powder free latex examination gloves with vanilla and protein content labeling claim (50 micrograms or less) SGMP CO., LTD. k012863 09/21/2001
interject injection therapy needle, models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 BOSTON SCIENTIFIC CORP. k012864 10/24/2001
superstitch vascular suturing device SUTURA, INC. k012865 09/25/2001

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