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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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sensi grip latex examination glove, powdered contains 200 mcgm or less of total water extractable protein per gram TILLOTSON HEALTHCARE CORP. k000745 05/03/2000
ultra care 2 latex examination gloves made from allotex (enzyme treated) natural rubber latex with a protein content lab TILLOTSON HEALTHCARE CORP. k002718 05/01/2001
formula one powdered latex examination glove, with protein content labeling claim 200 micrograms or less and made from a TILLOTSON HEALTHCARE CORP. k002719 01/26/2001
formula one sterile latex examination gloves with protein content labeling claim (200 micrograms or less) made from allo TILLOTSON HEALTHCARE CORP. k002720 11/09/2000
clini-dent THE PRECIDENT GROUP k000140 05/03/2000
olympus um 2r/3r ultrasonic probe and associated ancillary equipment for female reproductive tract THE OLYMPUS OPTICAL CO. k001203 05/26/2000
kippmed i.v. manifold THE KIPP GROUP k000152 02/29/2000
anca combi diagnostic kit with if-aim technology THE BINDING SITE, LTD. k001127 08/30/2000
c-reactive protein antiserum kit THE BINDING SITE, LTD. k001636 08/24/2000
cleanair/ cleanwater unit, model 1600 TEXAS INSTITUTE FOR CONSERVATIVE DENTISTRY k003265 12/22/2000

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