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

    BARD VISILEX MESH 3 X 6

    K Number: K953577 · Decision Sep 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    24
    Review Days
    57

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    Basic Information

    Device Name
    BARD VISILEX MESH 3 X 6
    K Number
    K953577
    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
    Davol Inc., Sub. C. R. Bard, Inc.
    Date Received
    July 31, 1995
    Decision Date
    September 26, 1995
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

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