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

    MODEL GLASE 210 HOLMIUM LASER SYSTEM

    K Number: K904248 · Decision Dec 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    88

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    Basic Information

    Device Name
    MODEL GLASE 210 HOLMIUM LASER SYSTEM
    K Number
    K904248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5070
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Charles L. Rose and Co., Inc.
    Date Received
    September 17, 1990
    Decision Date
    December 14, 1990
    Product Code
    HGF
    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
    HGF Source, Abortion Unit, Vacuum

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