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    K Number
    K120894
    Device Name
    HAYMAX
    Manufacturer
    HAYMAX LIMITED
    Date Cleared
    2012-05-17

    (55 days)

    Product Code
    NUP
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAYMAX LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HayMax™ organic pollen barrier balm is intended to promote alleviation of mild allergic symptons, (i.e, mild nasal irritation, including itchy, runny, or congested nasal passages), triggered by the inhalation of various airborne allergens including grass and tree pollen, house dust mite and animal dander.
    Device Description
    HayMax™ is a drug free viscous topical nasal balm consisting of a mixture of organic beeswax and organic sunflower oil. There are three further variants: one containing organic freeze dried 200:1 Aloe Vera powder, another containing organic Lavender essential oil and the last containing organic Frankincense essential oil, all in very small quantities. HayMax™ is used as a pollen blocker prophylaxis for seasonal allergic rhinitis caused by airborne allergens. The product is sparingly applied around the base of the nostrils with a finger, or suitable applicator, eq., cotton swab. where it acts as a mechanical barrier. It traps pollen before it reaches the nasal cavity, thus reducing pollen entering the body. If this maintains the pollen (or other airborne allergen) in a person's body below their sensitivity level then they will not react to the allergen. It is reapplied regularly as required, and after sneezing or blowing the nose. It is intended for topical use and is provided non-sterile. The balm is chemically inert to the body and nasal membranes, and is certified organic.
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