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510(k) Data Aggregation

    K Number
    K050418
    Device Name
    TISSUE FIXATION SYSTEM
    Manufacturer
    TFS MANUFACTURING PTY LTD
    Date Cleared
    2005-05-16

    (87 days)

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

    TFS MANUFACTURING PTY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TFS Device is intended to be used in females to position a polypropylene mesh tape for the treatment of Genuine Stress Urinary Incontinence, mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse.
    Device Description
    Tissue Fixation System (TFS Device)
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