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510(k) Data Aggregation

    K Number
    K024183
    Device Name
    ALTON PT STEPPER
    Manufacturer
    Date Cleared
    2003-03-17

    (88 days)

    Product Code
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTON DESIGN, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Alton PT Stabilizer and Stepper is designed to allow precision ultrasound probe alignment, precise prostate visualization and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. It is also used to allow precision ultrasound alignment and precise prostate visualization in cryotherapy treatments for prostate treatment.
    Device Description
    Not Found
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