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510(k) Data Aggregation

    K Number
    K062979
    Device Name
    THYROSAMPLER
    Date Cleared
    2007-05-30

    (243 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACD MEDICAL INNOVATION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Thyrosampler® Kurtaran Frass is indicated for ultrasound guided fine needle aspiration of soft thyroid nodules that are about 1 cm or greater in diameter, located up to depth of 4 cm from the skin.
    Device Description
    Not Found
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