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

    SURGICAL CHISEL/OSTEOTOME

    K Number: K894785 · Decision Aug 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    22

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    Basic Information

    Device Name
    SURGICAL CHISEL/OSTEOTOME
    K Number
    K894785
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Fdt Precision Machine Co., Inc.
    Date Received
    July 27, 1989
    Decision Date
    August 18, 1989
    Product Code
    KDG
    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
    KDG Chisel (Osteotome)

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