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510(k) Data Aggregation

    K Number
    K042427
    Device Name
    GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
    Manufacturer
    GENEMED, INC.
    Date Cleared
    2004-12-03

    (86 days)

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

    GENEMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter is indicated for use in the non-invasive disintegration of kidney (renal pelvis and renal calyceal) and upper ureteral stones between 5 and 20 mm in size.
    Device Description
    Not Found
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