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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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powder-free latex exam gloves with chocolate scenting and protein labeling claim (<50ug/g) SGMP CO., LTD. k012860 09/21/2001
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
xia stainless steel system HOWMEDICA OSTEONICS CORP. k012870 09/24/2001
superstitch vascular suturing device SUTURA, INC. k012865 09/25/2001
ultraflex ev hemostasis introducer ST. JUDE MEDICAL k012922 09/25/2001
the nexgen tmt tibia, models 00-5886-xxyy, 05-120-xxyy-0 IMPLEX CORP. k012866 09/26/2001
3i locater abutment system IMPLANT INNOVATIONS, INC. k012911 09/28/2001
bard utaverse small vessel pta balloon dilatation catheter C.R. BARD, INC. k012913 09/28/2001
modification to ensite 3000 system, model ee3000 ENDOCARDIAL SOLUTIONS, INC. k012926 09/28/2001
cell-dyn 3200 system with absolute and percent reticulocyte ABBOTT LABORATORIES k012934 09/28/2001

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