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    K Number
    K120844
    Device Name
    MEDLINX SURGICAL MESH
    Manufacturer
    MEDLINX ACALA PTE LTD
    Date Cleared
    2012-12-13

    (268 days)

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

    MEDLINX ACALA PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medlinx Surgical Mesh is intended to be implanted to reinforce soft tissue where weakness exists for the repair of hernias and other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
    Device Description
    The Medlinx Surgical Mesh is a sterile, implantable, single-layer polymeric mesh that is comprised of non-absorbable polyvinylidene fluoride (PVDF) and absorbable poly(1,4-butylene adipate) (PBA). The PBA plasticizer increases the flexibility of the mesh, and it is partially absorbed once implanted.
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