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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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access ck-mb on the access immunoassay analyzer, models 33300, 33305, 33309, 33306 BECKMAN COULTER, INC. k994439 01/14/2000
cynosure m2 dermatology laser for hair removal CYNOSURE, INC. k994427 01/18/2000
cynosure photogenica spir CYNOSURE, INC. k994437 01/18/2000
bilichek non-invasive bilirubin analyzer SPECTRX, INC. k994438 02/04/2000
opc 3g all-ceramic system, core and overlay porcelains JENERIC/PENTRON, INC. k994435 02/10/2000
hwa & silktex powdered latex examination gloves, with protein content labeling claim (140 micrograms or less) HWA TEH INDUSTRIAL SDN. BHD. k994432 02/16/2000
venusa, ltd. extension set with filter VENUSA LTD. k994429 03/03/2000
e7512 premie rem polyhesive ii patient return electrode VALLEYLAB, INC. k994428 03/07/2000
surgi-vision esophageal stylet coil SURGI-VISION, INC. k994436 03/14/2000
shimadzu whole body x-ray computed tomography scanner sct-7800 series SHIMADZU MEDICAL SYSTEMS k994431 03/23/2000

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