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510(k) Data Aggregation

    K Number
    DEN140022
    Device Name
    GLAUCOMA COMPANION
    Manufacturer
    Date Cleared
    2016-04-20

    (642 days)

    Product Code
    Regulation Number
    886.5838
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nasolacrimal Compression Device (NCD) is indicated to temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts.
    Device Description
    The Nasolacrimal Compression Device is a modified spectacle frame made of polyvinyl chloride (PVC) coated soft carbon steel wire covered with silicone rubber where the device contacts the nose bridge. The fastening bands are made from flame-retardant nylon hook and loop fabric. The frame width, nose bridge width, and nose pad shape of the subject device may be adjusted. The nose pad is contoured such that it lies over the nasal aspect of the orbital rims where the nasolacrimal systems are underneath. There are fastening bands attached to each temple that allow the user to adjust pressure applied to the nasolacrimal system.
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