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

    HASSON BUEC-3

    K Number: K820672 · Decision Jul 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    50
    Review Days
    141

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    Basic Information

    Device Name
    HASSON BUEC-3
    K Number
    K820672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Bivona Medical Technologies
    Date Received
    March 11, 1982
    Decision Date
    July 30, 1982
    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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