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

    CHISEL (OSTEOTOME, GOUGE, ETC.)

    K Number: K864775 · Decision Feb 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    3
    Applicant Total
    18
    Review Days
    69

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    Basic Information

    Device Name
    CHISEL (OSTEOTOME, GOUGE, ETC.)
    K Number
    K864775
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    New England Surgical Instrument Corp.
    Date Received
    December 5, 1986
    Decision Date
    February 12, 1987
    Product Code
    EMM
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EMM Chisel, Osteotome, Surgical

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