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

    SPECULITE DISPOSABLE VAGINAL LIGHT

    K Number: K853257 · Decision Dec 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    147

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    Basic Information

    Device Name
    SPECULITE DISPOSABLE VAGINAL LIGHT
    K Number
    K853257
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Trylon Associates, Ltd.
    Date Received
    August 2, 1985
    Decision Date
    December 27, 1985
    Product Code
    HIC
    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
    HIC Speculum, Vaginal, Nonmetal, Fiberoptic

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