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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
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c&b resin plus powder/liquid, models retemp a2, a3, a3.5, cl, retemp b2, b3, c2, d3, wh, retemp mo DENTAL VENTURES OF AMERICA, INC. k000894 05/19/2000
male latex comdom with dotted surface PLEASURE LATEX PRODUCTS SDN. BHD. k001221 05/19/2000
steller cd61 assay for use on the imagn 2000 microvolume fluorimeter BD Biosciences k000611 05/18/2000
additional assays for bayer advia ims system BAYER CORP. k000903 05/18/2000
bayer advia ims system; 200 + 3 BAYER CORP. k000921 05/18/2000
intercure ltd. respi-low INTERCURE LTD. k000405 05/17/2000
scandinavian ivf sciences ab, thaw-kit 1 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB k000618 05/17/2000
arachnophlebectomy needle ADVANCED MEDICAL PRODUCTS, INC. k000932 05/17/2000
otw megalink sds billiary stent system, models 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 GUIDANT CORP. k001222 05/17/2000
rx herculink 14 biliary stent system, models 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 GUIDANT CORP. k001224 05/17/2000

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