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

    DIGENE CERVICAL BRUSH

    K Number: K971586 · Decision Sep 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    72
    Applicant Total
    9
    Review Days
    141

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    Basic Information

    Device Name
    DIGENE CERVICAL BRUSH
    K Number
    K971586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digene Corp.
    Date Received
    May 1, 1997
    Decision Date
    September 19, 1997
    Product Code
    HHT
    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
    HHT Spatula, Cervical, Cytological

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