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510(k) Data Aggregation

    K Number
    K134003
    Device Name
    RHINIX NASAL FILTER
    Manufacturer
    RHINIX APS
    Date Cleared
    2014-09-04

    (251 days)

    Product Code
    NUP
    Regulation Number
    880.5045
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    Applicant Name (Manufacturer) :

    RHINIX APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RHINIX™ nasal filter for patients aged 6 years and older, with properties that allow unimpeded nasal breathing, is for the prevention or alleviation of seasonal allergic rhinitis (hay fever) and for seasonal or perennial allergies to other airborne allergens with a similar size fraction to grass pollen allergens.
    Device Description
    The device consists of a filtering membrane/media and a frame. The filtering membrane is a planar filter made of polypropylene non-woven fibers. The frame is made of medical grade SEBS compound which is a biocompatible polymer designed for human skin contact. Each filter section in each nostril is connected via the frame's u-shaped bridge. The device is made in multiple sizes. The device is inserted in the nostrils and is in contact with unbroken skin in the anterior vestibule of the nostrils (non-invasive). The device functions as a filtering device (mechanical barrier) that removes particles (pollen) from the inhaled air. The filter allows adequate air movement while breathing through the nose. The device is single-use and should only be used when exposed to allergens.
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