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

    CENTURION VAGINAL SPECULUM

    K Number: K897100 · Decision Mar 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    16
    Review Days
    85

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    Basic Information

    Device Name
    CENTURION VAGINAL SPECULUM
    K Number
    K897100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Tri-State Hospital Supply Corp.
    Date Received
    December 21, 1989
    Decision Date
    March 16, 1990
    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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