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

    IR-192 IMPLANT

    K Number: K874895 · Decision Feb 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    3
    Review Days
    86

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    Basic Information

    Device Name
    IR-192 IMPLANT
    K Number
    K874895
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Rads S.L., Inc.
    Date Received
    December 1, 1987
    Decision Date
    February 25, 1988
    Product Code
    IWA
    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
    IWA Source, Wire, Iridium, Radioactive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IWA), ordered by most recent decision date.

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    IRIDIUM 192 WIRES

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    WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD

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    Other Clearances by Rads S.L., Inc.

    K Number Device Name
    K903465 IR-192 IMPLANT
    K844248 IR-192 IMPLANT