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

    MINI-MILL

    K Number: K914035 · Decision Mar 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    MINI-MILL
    K Number
    K914035
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomedical Composites, Ltd.
    Date Received
    September 10, 1991
    Decision Date
    March 2, 1992
    Product Code
    EMI
    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
    EMI File, Bone, Surgical

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    Other Clearances by Biomedical Composites, Ltd.

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