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

    UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES

    K Number: K023767 · Decision Nov 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    22
    Review Days
    17

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    Basic Information

    Device Name
    UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
    K Number
    K023767
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Olympus Optical Co.
    Date Received
    November 12, 2002
    Decision Date
    November 29, 2002
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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