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510(k) Data Aggregation

    K Number
    K080376
    Device Name
    ONCOBIONIC SYSTEM
    Manufacturer
    ONCOBIONIC INCORPORATED
    Date Cleared
    2008-04-02

    (50 days)

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

    ONCOBIONIC INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oncobionic System is indicated for surgical ablation of soft tissuc
    Device Description
    The Oncobionic System includes additional treatment parameters. These additional treatment parameters allow for the application of the Oncobionic System to target and ablate additional volumes of soft tissue. The Oncobionic System with additional treatment parameters applies a I .EDC pulse or series of pulses between two clectrodes to cause an ablation clicel to occur. The fundamental application and design of the device has not changed, but new treatment parameters have been tested and added to the device to cause additional volumes of soft tissue ablation
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