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

    O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100

    K Number: K981724 · Decision Jun 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    4
    Review Days
    38

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    Basic Information

    Device Name
    O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100
    K Number
    K981724
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtrex, Inc.
    Date Received
    May 15, 1998
    Decision Date
    June 22, 1998
    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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