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

    MENTOR PERCUTANEOUS RENAL DILATOR SET

    K Number: K850355 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    61
    Review Days
    41

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    Basic Information

    Device Name
    MENTOR PERCUTANEOUS RENAL DILATOR SET
    K Number
    K850355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mentor Corp.
    Date Received
    January 30, 1985
    Decision Date
    March 12, 1985
    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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