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

    MODIFIED PALLADIUM SEED MODEL 100

    K Number: K874787 · Decision Dec 22, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    MODIFIED PALLADIUM SEED MODEL 100
    K Number
    K874787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Theragenics Corp.
    Date Received
    November 23, 1987
    Decision Date
    December 22, 1987
    Product Code
    IWI
    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
    IWI Source, Isotope, Sealed, Gold, Titanium, Platinum

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