Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K161991
    Device Name
    Curasite
    Date Cleared
    2017-03-03

    (227 days)

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

    IZUN PHARMACEUTICALS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For Prescription Use Indication: Under the supervision of a healthcare professional, Curasite is intended for the management of the following: - Diabetic foot ulcers - Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) - Pressure ulcers/sores (partial and full thickness) - 1st and 2nd degree partial thickness burns For Over-the-Counter Use Indication: For Over-the-Counter (OTC) use, Curasite may be used for the management of: - Minor abrasions - Minor lacerations - Minor cuts - Minor scalds and minor burns
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K103054
    Device Name
    PERIOPATCH
    Date Cleared
    2011-02-07

    (115 days)

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

    IZUN PHARMACEUTICALS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1