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510(k) Data Aggregation

    K Number
    K081327
    Device Name
    RELIMESH
    Manufacturer
    HERNIAMESH S.R.L.
    Date Cleared
    2008-06-19

    (38 days)

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

    HERNIAMESH S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects
    Device Description
    Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side. Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer These 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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    K Number
    K050516
    Device Name
    T-SLING
    Manufacturer
    HERNIAMESH S.R.L.
    Date Cleared
    2006-02-03

    (339 days)

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

    HERNIAMESH S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Sling is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse. The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
    Device Description
    The T-Sling is made of monofilament polypropylene warp knitted into composite mesh construction. The T-Sling is a sterile, single-use pubourethral sling for the treatment of stress urinary incontinence (SUI).
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