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    K Number
    K955657
    Device Name
    NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
    Manufacturer
    NORTH STATE PLASTICS, INC.
    Date Cleared
    1996-03-12

    (91 days)

    Product Code
    BYP
    Regulation Number
    868.5620
    Why did this record match?
    Product Code :

    BYP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Like the predicate devices, the North State Plastics Respiratory Mouthpiece is intended for use in providing a direct source of continuous aerosol medication.
    Device Description
    The device is injection molded from rigid, clean, chemically inert High Density Polyethylene. The Mouthpiece is equipped with a standard 22mm OD fitting for connection to most aerosol devices.
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