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510(k) Data Aggregation

    K Number
    K110728
    Device Name
    IMESH TACKER
    Manufacturer
    EASYLAP LTD.
    Date Cleared
    2011-06-08

    (84 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    EASYLAP LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iMESH Tacker is indicated for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
    Device Description
    The iMESH Tacker is a sterile, single use device for the fixation of prosthetic material, such as a hernia mesh, onto soft tissue. The applicator features an articulating tip. The absorbable tack is made of synthetic polyester derived from a lactic acid and glycolic acid copolymer. The Applicator is pre-loaded with 30 tacks.
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