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510(k) Data Aggregation

    K Number
    K162119
    Device Name
    UreTron PF Series Probe
    Manufacturer
    MED-SONICS CORP.
    Date Cleared
    2016-08-29

    (28 days)

    Product Code
    FFK
    Regulation Number
    876.4480
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-SONICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UreTron PF Series Probes are to be used with UreTron Multi Probe Lithotripsy System. UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
    Device Description
    Not Found
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