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

    E3 MICROPROBE

    K Number: K974878 · Decision Mar 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    2
    Review Days
    87

    Basic Information

    Device Name
    E3 MICROPROBE
    K Number
    K974878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MARTIN URAM, MD
    Date Received
    December 30, 1997
    Decision Date
    March 27, 1998
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by MARTIN URAM, MD

    K Number Device Name
    K000192 E3 MICROPROB SERIES OF LASERS AND ACCESSORIES