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510(k) Data Aggregation
K Number
K120894Device Name
HAYMAX
Manufacturer
HAYMAX LIMITED
Date Cleared
2012-05-17
(55 days)
Product Code
NUP
Regulation Number
880.5045Why 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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