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510(k) Data Aggregation

    K Number
    K162366
    Device Name
    Omega VL
    Manufacturer
    OV WORLD CO., LTD
    Date Cleared
    2018-03-02

    (556 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    OV WORLD CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Omega V L comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
    Device Description
    This device is made of polydioxanone and has bi-directional barbs along the long axis of the suture monofilament without needle attachment
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