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

    CARBON DIOXIDE LASER ML 825

    K Number: K833528 · Decision Feb 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    6
    Review Days
    515

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    Basic Information

    Device Name
    CARBON DIOXIDE LASER ML 825
    K Number
    K833528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Merrimack Laboratories
    Date Received
    September 23, 1983
    Decision Date
    February 19, 1985
    Product Code
    HHR
    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
    HHR Laser, Surgical, Gynecologic

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