BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VARIOUS AFTERLOADING APPLICATORS

    K Number: K904933 · Decision Jan 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    64

    Basic Information

    Device Name
    VARIOUS AFTERLOADING APPLICATORS
    K Number
    K904933
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    BEST ASSOC. CORP.
    Date Received
    November 1, 1990
    Decision Date
    January 4, 1991
    Product Code
    IWJ
    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
    IWJ System, Applicator, Radionuclide, Manual

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