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510(k) Data Aggregation

    K Number
    K982929
    Device Name
    MAXAIR NASAL DILATOR SYSTEM
    Manufacturer
    HNL TECHNOLOGIES
    Date Cleared
    1998-09-09

    (20 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    HNL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MaxAir™ Nasal Dilator is intended to be used to enhance the flow of air through the nose. The nasal dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing. The MaxAir™ Nasal Dilator's uses include, but are not limited to persons with temporary symptoms of nasal congestion which may be caused by colds, deviated septums, allergic rhinitis, and alar and valve insufficiency. The reduction of resistance to air flow in the nasal passage can also reduce the onset of snoring due to restrictions to air flow through the nasal passages.
    Device Description
    The MaxAir™ Nasal Dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing.
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