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

    STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE

    K Number: K890973 · Decision Mar 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    28
    Review Days
    23

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    Basic Information

    Device Name
    STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE
    K Number
    K890973
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Instrument Makar, Inc.
    Date Received
    February 27, 1989
    Decision Date
    March 22, 1989
    Product Code
    JOS
    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
    JOS Electrode, Electrosurgical

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