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

    MODIFIED SPACEMAKER SYSTEM

    K Number: K042412 · Decision Sep 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    1391
    Applicant Total
    218
    Review Days
    17

    Basic Information

    Device Name
    MODIFIED SPACEMAKER SYSTEM
    K Number
    K042412
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Received
    September 7, 2004
    Decision Date
    September 24, 2004
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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