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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
Number
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Decision
Date
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diamedix is-anti-dsdna test system DIAMEDIX CORP. k994424 02/18/2000
modification to endoscopic spinal access system ENDIUS, INC. k994425 02/16/2000
glovetex, latex examination gloves, powdered non-sterile.(protein content labeling) PT. WRP BUANA MULTICORPORA k994426 05/23/2000
cynosure m2 dermatology laser for hair removal CYNOSURE, INC. k994427 01/18/2000
e7512 premie rem polyhesive ii patient return electrode VALLEYLAB, INC. k994428 03/07/2000
venusa, ltd. extension set with filter VENUSA LTD. k994429 03/03/2000
impact.wf mobile waveform receiving system GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN k994430 03/28/2000
shimadzu whole body x-ray computed tomography scanner sct-7800 series SHIMADZU MEDICAL SYSTEMS k994431 03/23/2000
hwa & silktex powdered latex examination gloves, with protein content labeling claim (140 micrograms or less) HWA TEH INDUSTRIAL SDN. BHD. k994432 02/16/2000
connect data management system ABBOTT DIABETES CARE INC. k994433 05/05/2000

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