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510(k) Data Aggregation

    K Number
    K021775
    Device Name
    LTFS230
    Manufacturer
    HEALTHTRONICS, INC.
    Date Cleared
    2002-12-23

    (208 days)

    Product Code
    LNS
    Regulation Number
    876.5990
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.
    Device Description
    The LithoDiamond is an Extracorporeal Shock Wave Lithotripter. The primary difference in the devices is that the LithoDiamond has a new imaging system.
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