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

    STUART TITANIUM SURGICAL MESH

    K Number: K890601 · Decision Mar 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    11
    Applicant Total
    5
    Review Days
    38

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    Basic Information

    Device Name
    STUART TITANIUM SURGICAL MESH
    K Number
    K890601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Stuart
    Date Received
    February 6, 1989
    Decision Date
    March 16, 1989
    Product Code
    EZX
    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
    EZX Mesh, Surgical, Metal

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