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

    BIOLUCENT APPLICATOR KIT

    K Number: K062830 · Decision Oct 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    BIOLUCENT APPLICATOR KIT
    K Number
    K062830
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biolucent, Inc.
    Date Received
    September 20, 2006
    Decision Date
    October 20, 2006
    Product Code
    JAQ
    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
    JAQ System, Applicator, Radionuclide, Remote-Controlled

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