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

    PROSTATE IMMOBILIZER RECTAL BALLOON

    K Number: DEN130036 · Decision Jan 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    197

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    Basic Information

    Device Name
    PROSTATE IMMOBILIZER RECTAL BALLOON
    K Number
    DEN130036
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.5720
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Radiadyne
    Date Received
    July 15, 2013
    Decision Date
    January 28, 2014
    Product Code
    PCT
    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
    PCT Prostate Immobilizer Rectal Balloon

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