BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    LEAD BLOCKS

    K Number: K010172 · Decision Apr 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    49
    Applicant Total
    9
    Review Days
    90

    Basic Information

    Device Name
    LEAD BLOCKS
    K Number
    K010172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ARPLAY MEDICAL S.A.
    Date Received
    January 18, 2001
    Decision Date
    April 18, 2001
    Product Code
    IXI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IXI Block, Beam-Shaping, Radiation Therapy

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