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510(k) Data Aggregation

    K Number
    K971677
    Device Name
    ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD
    Date Cleared
    1997-08-20

    (105 days)

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

    TRANSAMERICAN TECHNOLOGIES INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACCU-Surg Bipolar Laparoscopic Electrodes are intended to be used with the ACCU-Surg Suction / Irrigation Cannula. They are surgical tools for cutting and coagulation used for GYN and General Surgery for such procedures as coagulation of endometrium, laparoscopic myomectomy, laparoscopic leiomyoma coagulation (myolysis), bleeding control of pelvic vessels and laparoscopic (**) errors )) bacanth orgeons choice will determine the tip style used.
    Device Description
    Not Found
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    K Number
    K963193
    Device Name
    ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39
    Date Cleared
    1996-11-13

    (90 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSAMERICAN TECHNOLOGIES INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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