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

    GLIASITE RTS

    K Number: K111931 · Decision Aug 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    GLIASITE RTS
    K Number
    K111931
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isoray Medical, Inc.
    Date Received
    July 8, 2011
    Decision Date
    August 5, 2011
    Product Code
    KXK
    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
    KXK Source, Brachytherapy, Radionuclide

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