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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)
Number
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Decision
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powder free latex examination patient gloves PURNABINA SDN BHD k994420 09/18/2000
snn stereotaxic planning application; snn stereotactic application SURGICAL NAVIGATION SPECIALISTS, INC. k994421 02/23/2000
automated non-invasive blood pressure monitor, model bpm-100 VSM MEDTECH LTD. k994423 03/28/2000
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

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