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510(k) Data Aggregation

    K Number
    K182087
    Device Name
    DynaMesh-POSTERIOR
    Manufacturer
    FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft
    Date Cleared
    2018-10-31

    (90 days)

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

    FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DynaMesh®- POSTERIOR serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®- POSTERIOR is indicated for repairing hernias in all current extraperitoneal surgical techniques.
    Device Description
    The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-POSTERIOR is a textile structure knitted from non-absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 from Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a ziqzag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates a rapid orientation and visual monitoring of whether the mesh is positioned tension-free. The used green dye is Phtalocyanine green, CAS1328-53-6, PG7 from BASF. DynaMesh®-POSTERIOR is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-POSTERIOR will be packed in a cardboard box. Within the cardboard box the device will be doublepacked in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.
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