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

    SMD-Sr90-DA Radionuclide Brachytherapy Source

    K Number: K163206 · Decision Dec 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    SMD-Sr90-DA Radionuclide Brachytherapy Source
    K Number
    K163206
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Salutaris Medical Devices, Inc.
    Date Received
    November 15, 2016
    Decision Date
    December 15, 2016
    Product Code
    KXK
    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
    KXK Source, Brachytherapy, Radionuclide

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    Other Clearances by Salutaris Medical Devices, Inc.

    K Number Device Name
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