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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    NORTH STATE PLASTICS, INC.

    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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    K Number
    K955656
    Device Name
    NORTH STATE PLASTICS AEROSOL TEE
    Manufacturer
    NORTH STATE PLASTICS, INC.
    Date Cleared
    1996-03-06

    (85 days)

    Product Code
    BYX
    Regulation Number
    868.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH STATE PLASTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Like the predicate devices, the North State Plastics Aerosol Tee is intended for use in providing a conduit for aerosol medications and respiratory gases.
    Device Description
    The device is injection molded from clear, rigid, clean, chemically inert K-Resin KRO3-NW. The Aerosol Tee is equipped with standard 18 and 22 mm OD fittings for connection to most aerosol devices.
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