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

    DANEK IRRIGATING BURR (DIB) SET

    K Number: K890090 · Decision Jan 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    15
    Applicant Total
    56
    Review Days
    14

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    Basic Information

    Device Name
    DANEK IRRIGATING BURR (DIB) SET
    K Number
    K890090
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Danek Medical, Inc.
    Date Received
    January 10, 1989
    Decision Date
    January 24, 1989
    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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