BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LTN - LAPAROSCOPIC SURGICAL MESH

    K Number: K130817 · Decision Apr 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    23

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    Basic Information

    Device Name
    LTN - LAPAROSCOPIC SURGICAL MESH
    K Number
    K130817
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifecell Corp.
    Date Received
    March 25, 2013
    Decision Date
    April 17, 2013
    Product Code
    OXK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects

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