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    K Number
    K051812
    Device Name
    TGO SPRAY
    Manufacturer
    LABORATOIRES CARILENE S.A.S.
    Date Cleared
    2005-10-21

    (108 days)

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

    LABORATOIRES CARILENE S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, TGO Spray® is intended to provide relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. TGO Spray® relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste.
    Device Description
    TGO Spray® is an oral artificial saliva that contains oxygenated triglycerides from corn oil that have lubricating and moisturizing properties. The product is preserved, and supplied in a glass spray bottle containing 40 mL (1.35 fl.oz.). The spray pump delivers a metered dose of 0.100 mL per spray or approximately 400 sprays.
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