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    K Number
    K201153
    Device Name
    Tisuthes e-PTFE Surgical Patch
    Manufacturer
    Shanghai Suokang Medical Implants Co., Ltd.
    Date Cleared
    2023-06-13

    (1139 days)

    Product Code
    OWRFTL
    Regulation Number
    878.3300
    Why did this record match?
    Product Code :

    OWR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TisuthesTM e-PTFE Surgical Patches are indicated for facial plastic and reconstructive surgery.
    Device Description
    Tisuthes™ e-PTFE Surgical Patches are intended for facial plastic and reconstruction surgery. The device is provided sterile. The device is available in the forms of sheets, blocks and preformed three-dimensional forms (chin, nasal, temporal piriform and malar) with multiple sizes.
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