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510(k) Data Aggregation

    K Number
    K113311
    Device Name
    TIO2MESH TM
    Date Cleared
    2012-07-17

    (251 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCER ENTWICKLUNGS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TiO2Mesh™ is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO2Mesh™ can be used for both laparoscopic and other open procedures.
    Device Description
    TiO2Mesh™ is made from a monofilament polypropylene thread and has a large-pore structure with blue orientation stripes. The surgical mesh implant has a titanium dioxide coated surface. The fabric can be stretched in both directions and is highly flexible to react to body dynamics in terms of elasticity. TiO2Mesh™ is available in different shapes and sizes (product flyer TiO2Mesh™ ).
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