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510(k) Data Aggregation

    K Number
    K062653
    Device Name
    MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
    Manufacturer
    PARNELL PHARMACEUTICALS, INC.
    Date Cleared
    2006-10-27

    (50 days)

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

    PARNELL PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves dry mouth conditions
    Device Description
    MouthKote is an artificial saliva substitute which contains moisturizers. polysaccharides and flavones that have lubricating and moistening properties. It contains patented Yerba Santa extract which has a FDA GRAS number and FEMA number. Products are supplied in 5ml tube, 2 fluid oz. and 8 fluid oz. bottles.
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