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

    UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450

    K Number: K010296 · Decision Apr 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    86
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
    K Number
    K010296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marina Medical Instruments, Inc.
    Date Received
    January 31, 2001
    Decision Date
    April 11, 2001
    Product Code
    LKF
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKF Cannula, Manipulator/Injector, Uterine

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