BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    EURO-COLLINS SOLUTION SETS

    K Number: K884609 · Decision Jan 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    18
    Applicant Total
    38
    Review Days
    80

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    Basic Information

    Device Name
    EURO-COLLINS SOLUTION SETS
    K Number
    K884609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Fresenius USA, Inc.
    Date Received
    November 7, 1988
    Decision Date
    January 26, 1989
    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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