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    K Number
    K082962
    Device Name
    TIVAMED COOLED RF SYSTEM, MODEL 78001
    Manufacturer
    TIVAMED, INC.
    Date Cleared
    2008-12-04

    (62 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TIVAMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    TivaMed Cooled RF System uses radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool and protect the surface tissue.
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