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

    AMS LARGE PORE POLYPROPHLENE MESH

    K Number: K121805 · Decision Oct 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    119

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    Basic Information

    Device Name
    AMS LARGE PORE POLYPROPHLENE MESH
    K Number
    K121805
    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
    American Medical Systems
    Date Received
    June 19, 2012
    Decision Date
    October 16, 2012
    Product Code
    OTO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

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