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510(k) Data Aggregation

    K Number
    K062081
    Device Name
    LITHOGOLD
    Manufacturer
    TISSUE REGENERATION TECHNOLOGIES, INC.
    Date Cleared
    2006-11-02

    (104 days)

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

    TISSUE REGENERATION TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
    Device Description
    The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities. The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis NUW -- 2 2005 Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.
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