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

    TRACERS BONE CEMENT OPACIFIER

    K Number: K023445 · Decision Mar 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    147

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    Basic Information

    Device Name
    TRACERS BONE CEMENT OPACIFIER
    K Number
    K023445
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Parallax Medical, Inc.
    Date Received
    October 15, 2002
    Decision Date
    March 11, 2003
    Product Code
    MYU
    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
    MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

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