BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KOMET SURGICAL BUR

    K Number: K883255 · Decision Sep 15, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    44

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    Basic Information

    Device Name
    KOMET SURGICAL BUR
    K Number
    K883255
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Komet Medical, Div. of Brasseler USA I, L.P.
    Date Received
    August 2, 1988
    Decision Date
    September 15, 1988
    Product Code
    GFF
    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
    GFF Bur, Surgical, General & Plastic Surgery

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