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510(k) Data Aggregation

    K Number
    K080466
    Device Name
    ALCOHOL PAD
    Manufacturer
    122 CORPORATION
    Date Cleared
    2008-10-21

    (243 days)

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

    122 CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curos™ Port Protector is a device containing 70% Isopropyl alcohol. When left in place for 5 to 15 minutes the Curos™ Port Protector decontaminates the injection port; thereafter the Curos™ Port Protector provides a physical barrier during the intended use.
    Device Description
    The Curos™ Port Protector device is a single use, non-sterile device that contains 70% Isopropyl Alcohol and is intended to be used to decontaminate needleless luer activated valves.
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