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510(k) Data Aggregation

    K Number
    K023733
    Device Name
    COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
    Manufacturer
    INGENJORSFIRMAN BJORN BERGDAHL AB
    Date Cleared
    2003-05-14

    (189 days)

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

    INGENJORSFIRMAN BJORN BERGDAHL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Coagulation of soft tissue during surgery.
    Device Description
    Coa-Comp/M Automatic Bipolar Coagulator. Class II device. For coagulation of soft tissue during surgery using Radio Frequency, a pure sine-wave with frequency 512 kHz. Maximum power output 40W into 100 Ohms.
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