BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LABELING CHANGE - VIASPAN(TM) (BELZER UW)

    K Number: K900492 · Decision Mar 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    18
    Applicant Total
    13
    Review Days
    46

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    Basic Information

    Device Name
    LABELING CHANGE - VIASPAN(TM) (BELZER UW)
    K Number
    K900492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The DU Pont Co.
    Date Received
    February 2, 1990
    Decision Date
    March 20, 1990
    Product Code
    KDL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KDL Set, Perfusion, Kidney, Disposable

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