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

    IRIDIUM 192 WIRES & PINS

    K Number: K771878 · Decision Oct 27, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    9
    Review Days
    23

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    Basic Information

    Device Name
    IRIDIUM 192 WIRES & PINS
    K Number
    K771878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Cis Radiopharmaceuticals, Inc.
    Date Received
    October 4, 1977
    Decision Date
    October 27, 1977
    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

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    IRIDIUM SEEDS

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    IRIDIUM 192 WIRES

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    Other Clearances by Cis Radiopharmaceuticals, Inc.

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    K791202 RIA KIT FOR TRYPSIN
    K792000 LUTEINIZING HORMONE (LH) RIA
    K791051 PROGESTERONE RADIOIMMUNOASSAY KIT
    K790003 RIA KIT, PROLACTIN
    K780982 KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT
    K760251 SET, ORAL ADMINISTRATION