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510(k) Data Aggregation

    K Number
    K101769
    Device Name
    EPISIL
    Manufacturer
    Date Cleared
    2011-09-13

    (446 days)

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

    CAMURUS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    episil® has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy).
    Device Description
    episil® is a medical device constituting an oromucosal liquid in a multidose container and is without active pharmaceutical ingredient. The oromucosal liquid transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid. episil® has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including Oral Mucositis/ Stomatitis (may be caused by chemotherapy or radiotherapy). The oromucosal liquid is made of six ingredients including glycerol dioleate, soy phosphatidyl choline, ethanol, propylene glycol, polysorbate 80, and peppermint oil, which are all GRAS for the intended use.
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