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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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Decision
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vectorsurge 4 interferential therapy unit model vs 460 METRON MEDICAL AUSTRALIA PTY LTD k003260 02/22/2001
vcf personal lubricant APOTHECUS PHARMACEUTICAL CORP. k010182 03/09/2001
vascular assist HUNTLEIGH HEALTHCARE, INC. k002186 05/02/2001
varis 1.4g VARIAN MEDICAL SYSTEMS, INC. k001643 06/23/2000
v score with auto gate model tbd VITAL IMAGES, INC. k003230 12/27/2000
urea-l3k assay, catalogue number 283-17/30 DIAGNOSTIC CHEMICALS LTD. k002694 09/15/2000
univec two piece syringe UNIVEC, INC. k000747 06/08/2000
unipolar needles PAJUNK GMBH k000722 03/31/2000
ultrapen reusable pencil, model 130350 through 130353, reusable accessory electrode kit (for use with ultrapen pencil), CONMEDCORP k001161 06/07/2000
ultraedge keratome blade, model 374803 - acs LASERSIGHT TECHNOLOGIES, INC. k001144 05/05/2000

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