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

    PLASTIC-GUIDES

    K Number: K901842 · Decision Jul 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    78

    Basic Information

    Device Name
    PLASTIC-GUIDES
    K Number
    K901842
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.5650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    M & K CO.
    Date Received
    April 24, 1990
    Decision Date
    July 11, 1990
    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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