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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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steller cd61 assay for use on the imagn 2000 microvolume fluorimeter BD Biosciences k000611 05/18/2000
acumatch l-series cemented femoral stem, model l-series cemented EXACTECH, INC. k001335 05/18/2000
palomar slp 2000 PALOMAR MEDICAL TECHNOLOGIES, INC. k994225 05/18/2000
customcornea measurement device (ccmd) ALCON LABORATORIES, INC. k000637 05/19/2000
modification to agilent technologies anesthesia gas monitor, model m1026a #co5 AGILENT TECHNOLOGIES, GMBH k994188 05/19/2000
cardtel, model nt-100 CARDIAC TELECOMMUNICATIONS k000609 05/23/2000
scandinavian ivf sciences ab, g1.2 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB k000625 05/23/2000
scandinavian ivf sciences ab, gamete-100 VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB k000626 05/23/2000
guthrie powder-free latex surgical glove with (50 micrograms or less) GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD k001049 05/23/2000
disposable powdered nitrile exam glove, blue color SHEEN MORE ENT. CO., LTD. k001065 05/23/2000

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