BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    LEESPEC DISPOSABLE VAGINAL SPECULUM

    K Number: K021017 · Decision Jun 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    LEESPEC DISPOSABLE VAGINAL SPECULUM
    K Number
    K021017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Itl Corporation Pty, Ltd.
    Date Received
    March 29, 2002
    Decision Date
    June 19, 2002
    Product Code
    HIB
    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
    HIB Speculum, Vaginal, Nonmetal

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