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510(k) Data Aggregation

    K Number
    K103054
    Device Name
    PERIOPATCH
    Manufacturer
    IZUN PHARMACEUTICALS CORPORATION
    Date Cleared
    2011-02-07

    (115 days)

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

    IZUN PHARMACEUTICALS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PerioPatch is intended for the management of all types of oral wounds, injuries and ulcerations of the gingiva and oral mucosa, including stomatitis, minor chaffins and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery. PerioPatch operates to relieve pain by adharing to and protecting affected tissues from further irritation, thereby allowing healing.
    Device Description
    Not Found
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