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510(k) Data Aggregation

    K Number
    K142657
    Device Name
    XEROSTOM SALIVA SUBSTITUTE GEL
    Manufacturer
    BIO COSMETICS, S.L.
    Date Cleared
    2015-09-14

    (361 days)

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

    BIO COSMETICS, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth.
    Device Description
    Not Found
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