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

    COLPO CUP CVC-2000

    K Number: K974563 · Decision Mar 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    87

    Basic Information

    Device Name
    COLPO CUP CVC-2000
    K Number
    K974563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Innovations, Inc.
    Date Received
    December 5, 1997
    Decision Date
    March 2, 1998
    Product Code
    HDP
    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
    HDP Elevator, Uterine

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    Other Clearances by Clinical Innovations, Inc.

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