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

    NEPHROSTOMY/BILIARY DRAINAGE BAG

    K Number: K834476 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    21
    Review Days
    46

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    Basic Information

    Device Name
    NEPHROSTOMY/BILIARY DRAINAGE BAG
    K Number
    K834476
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Vertex Medical Corp.
    Date Received
    December 20, 1983
    Decision Date
    February 4, 1984
    Product Code
    LJE
    Advisory Committee
    Unknown
    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
    LJE Catheter, Nephrostomy

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