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510(k) Data Aggregation

    K Number
    K190806
    Device Name
    Flowart
    Manufacturer
    ASSET MEDIKAL TASARIM A.S.
    Date Cleared
    2020-02-20

    (328 days)

    Product Code
    FPAFMG
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASSET MEDIKAL TASARIM A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. Stopcocks are intended for use to change the direction of fluids through a tubing set. Needleless valve allows the user to add medication into the without the use of a needle.
    Device Description
    Not Found
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