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510(k) Data Aggregation

    K Number
    K971499
    Device Name
    FEMALE EXTERNAL URINARY COLLECTION POUCH
    Manufacturer
    MEDIQUEST, INC.
    Date Cleared
    1997-08-28

    (125 days)

    Product Code
    EXI
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIQUEST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.
    Device Description
    Mediquest, Inc.'s Female External Urinary Collection Pouch
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