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

    URS-HYDRO-DILATOR MODEL NUMBER 2164.00

    K Number: K912331 · Decision Oct 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    142
    Review Days
    159

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    Basic Information

    Device Name
    URS-HYDRO-DILATOR MODEL NUMBER 2164.00
    K Number
    K912331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    May 24, 1991
    Decision Date
    October 30, 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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