Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K163476
    Device Name
    Lubricity
    Date Cleared
    2017-05-10

    (149 days)

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

    You First Services, Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lubricity® Moisturizing Mouth Spray's intended use is to relieve the symptoms of dry mouth, refresh, moisturize, soothe oral irritation and lubricate dryness in and around the oral cavity.
    Device Description
    Lubricity® is an oral saliva substitute containing gel film forming polysaccharides, Sodium Hyaluronate, which has lubricating and moisturizing properties in the buccal cavity. The product is formulated, preserved and packed in blow molded polyethylene terephthalate bottles with a closure system comprising a metered dose liquid spray fitting manufactured from polypropylene, high density polyethylene, polymethoxylene copolymer and stainless steel (spring). All container closure components have appropriate status under FDA food contact or GRAS regulations.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1