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

    COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM

    K Number: K140754 · Decision Oct 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    211

    Basic Information

    Device Name
    COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
    K Number
    K140754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1630
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COOPER SURGICAL, INC.
    Date Received
    March 26, 2014
    Decision Date
    October 23, 2014
    Product Code
    HEX
    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
    HEX Colposcope (And Colpomicroscope)

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