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    K Number
    K153084
    Device Name
    Nephros S100
    Manufacturer
    NEPHROS INC.
    Date Cleared
    2016-04-08

    (165 days)

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

    NEPHROS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The S100 Point of Use Filter is intended to be used to filter EPA quality drinking water. The filter retains bacteria. By retaining bacteria in water for washing and drinking, the filter may aid in infection control. The filter produces water that is suitable for cleaning of equipment used in medical procedures and washing of surgeon's hands. The filter is not intended to provide water that can be used as a substitute for USP sterile water.
    Device Description
    The S100 Point of Use Filter is a hollow fiber microfilter that retains bacteria from water used for washing and drinking.
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