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

    MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III

    K Number: K896541 · Decision Jan 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    27
    Review Days
    75

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    Basic Information

    Device Name
    MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III
    K Number
    K896541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Valley Forge Scientific Corp.
    Date Received
    November 15, 1989
    Decision Date
    January 29, 1990
    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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