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510(k) Data Aggregation

    K Number
    K121833
    Device Name
    OSTOMY IRRIGATION SET
    Manufacturer
    COLOPLAST A/S
    Date Cleared
    2012-07-16

    (24 days)

    Product Code
    EXD
    Regulation Number
    876.5895
    Why did this record match?
    Product Code :

    EXD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Irrigation Set is indicated for people with a stoma who want to irrigate.
    Device Description
    The Irrigation Set is a Class II device, consisting of a single-use sleeve; a water bag (500-2000 ml) to hold water, a regulator where the paddle wheel that is integrated in the regulator gives visual assurance that water is entering the colon, a tube with a cone-shaped tip, a press plate and belt which are reusable devices. The Irrigation Set is provided with a nylon storage case.
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