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510(k) Data Aggregation

    K Number
    K051409
    Device Name
    SLIVASURE
    Manufacturer
    SCANDINAVIAN FORMULAS, INC.
    Date Cleared
    2005-08-08

    (69 days)

    Product Code
    LED
    Regulation Number
    864.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCANDINAVIAN FORMULAS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SalivaSure™ promotes lubrication of oral mucosa that may be dry due to the side effects of medication, chemo or radiotherapy, or as a symptom of Sjogren's Synolome, or because of orar real inflammation. SalivaSure™ provides temporary relief from dry mouth caused by reduced or damaged salivary function. The Over The Counter labeling indicates that SalivaSure™ is suitable for relief from dry mouth.
    Device Description
    Not Found
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