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

    NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M

    K Number: K000079 · Decision Feb 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    30
    Applicant Total
    15
    Review Days
    24

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    Basic Information

    Device Name
    NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
    K Number
    K000079
    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
    Nikomed U.S.A., Inc.
    Date Received
    January 11, 2000
    Decision Date
    February 4, 2000
    Product Code
    HAM
    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
    HAM Apparatus, Electrosurgical

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