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

    ACCENT DG BALLOON URETERAL DILATOR SET

    K Number: K905375 · Decision Apr 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    104
    Review Days
    133

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    Basic Information

    Device Name
    ACCENT DG BALLOON URETERAL DILATOR SET
    K Number
    K905375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cook Urological, Inc.
    Date Received
    November 30, 1990
    Decision Date
    April 12, 1991
    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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