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510(k) Data Aggregation

    K Number
    K100546
    Device Name
    PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
    Manufacturer
    PARKERMEDICALINC
    Date Cleared
    2010-06-03

    (98 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARKERMEDICALINC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tracheal tube designed for oral and nasal intubation and indicated for airway management.
    Device Description
    Sterile, single-use device for use in anesthesia and emergent and respiratory care. Center-beveled, flexible, curved, slightly rounded, tapered distal tip. Curved and preformed (shaped) tube configurations. Two facing Murphy eyes flanking the bevel. Polyvinyl chloride material with a barium sulfate filled stripe along the length of the device.
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