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

    MEDSCOPE 8MM AND 10MM LAPAROSCOPE

    K Number: K903663 · Decision Feb 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    2
    Review Days
    546

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    Basic Information

    Device Name
    MEDSCOPE 8MM AND 10MM LAPAROSCOPE
    K Number
    K903663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Medscope Corp.
    Date Received
    August 14, 1990
    Decision Date
    February 11, 1992
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

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