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510(k) Data Aggregation

    K Number
    K991916
    Device Name
    VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
    Date Cleared
    2000-01-14

    (221 days)

    Product Code
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIRGINIA WATER SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
    Device Description
    Virginia Water Systems' Water Purification for Hemodialysis is complete water treatment system used in the production of ultrapure water used in hemodialysis facilities. The components consist of the following: Blend Valve, Inlet Booster Pump, Multimedia Filter, Softener, Carbon Tanks, Reverse Osmosis Unit, Water Storage Tank, Repressure Pumps, Deionizer, Ultraviolet Light, Submicron Filter, Hollow Fiber Filter.
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