BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DB-CMF

    K Number: K182742 · Decision Jun 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    43
    Applicant Total
    5
    Review Days
    265

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    Basic Information

    Device Name
    DB-CMF
    K Number
    K182742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dimensional Bioceramics, LLC
    Date Received
    September 28, 2018
    Decision Date
    June 20, 2019
    Product Code
    GXP
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXP Methyl Methacrylate For Cranioplasty

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