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

    Avance Abdominal Dressing Kit

    K Number: K161939 · Decision Nov 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    1
    Applicant Total
    27
    Review Days
    126

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    Basic Information

    Device Name
    Avance Abdominal Dressing Kit
    K Number
    K161939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Molnlycke Health Care Us, LLC
    Date Received
    July 14, 2016
    Decision Date
    November 17, 2016
    Product Code
    OXJ
    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
    OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

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