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510(k) Data Aggregation

    K Number
    K070625
    Device Name
    PELVIMESH / HERMESH 7
    Manufacturer
    MARKETING SOLUTIONS INC.
    Date Cleared
    2007-08-01

    (148 days)

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

    MARKETING SOLUTIONS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hermesh 7 monofilament polypropylene mesh may be used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures.
    Device Description
    Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted monofilaments of extruded polypropylene. They are warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling. They maintain excellent isotropic properties because of its knitted construction. Hermesh 7 polypropylene meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body. The devices are supplied as sterile, single-use surgical meshes.
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