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

    AMER. EDWARDS LAB DIAFLEX URETERAL DILA

    K Number: K842639 · Decision Oct 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    55
    Applicant Total
    89
    Review Days
    85

    Basic Information

    Device Name
    AMER. EDWARDS LAB DIAFLEX URETERAL DILA
    K Number
    K842639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    AMERICAN EDWARDS LABORATORIES
    Date Received
    July 9, 1984
    Decision Date
    October 2, 1984
    Product Code
    EZN
    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
    EZN Dilator, Catheter, Ureteral

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