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

    MANAN V.S. ACCESS NEEDLE/SET

    K Number: K963767 · Decision May 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    464
    Applicant Total
    39
    Review Days
    239

    Basic Information

    Device Name
    MANAN V.S. ACCESS NEEDLE/SET
    K Number
    K963767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MANAN MEDICAL PRODUCTS, INC.
    Date Received
    September 19, 1996
    Decision Date
    May 16, 1997
    Product Code
    FGE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FGE Stents, Drains And Dilators For The Biliary Ducts

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