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510(k) Data Aggregation

    K Number
    K092224
    Device Name
    TIGR SURGICAL MESH , MODEL WK-6
    Manufacturer
    NOVUS SCIENTIFIC PTE LTD
    Date Cleared
    2010-01-25

    (186 days)

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

    NOVUS SCIENTIFIC PTE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TIGR™ Matrix Surgical Mesh is indicated for use in reinforcement of soft tissue where weakness exists.
    Device Description
    TIGR Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The first fiber, making up 40% of the matrix by weight, is a copolymer of polyglycolide, polylactide, and polytrimethylene carbonate. The second fiber, making up 60% of the matrix by weight, is a copolymer of polylactide, and polytrimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.
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