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510(k) Data Aggregation

    K Number
    K052622
    Device Name
    MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
    Manufacturer
    MACAN ENGINEERING CO.
    Date Cleared
    2005-12-09

    (77 days)

    Product Code
    EKZ, CLA
    Regulation Number
    872.4920
    Why did this record match?
    Applicant Name (Manufacturer) :

    MACAN ENGINEERING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Soft tissue management within the oral cavity to address the indications for incision, excision and ess of the success in and caff to comboof ties o Soft tissue managements in intra-oral soft tissue.
    Device Description
    The MC-4A dental electrosurgical unit is an AC powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended a controlled power of thissue or to control bleeding during surgery in the oral cavity. An electrical to our of the tip of the tip of the electrode into tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.
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    K Number
    K050735
    Device Name
    MC6A
    Manufacturer
    MACAN ENGINEERING CO.
    Date Cleared
    2005-05-23

    (63 days)

    Product Code
    EKZ, CLA
    Regulation Number
    872.4920
    Why did this record match?
    Applicant Name (Manufacturer) :

    MACAN ENGINEERING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Soft tissue management within the oral cavity to address the indications for incision, excision and in the states in interested soft tissue. Soft tissue management while as a soft tissue.
    Device Description
    The Radiosurge MC6A device is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended to cut or remove soft tissue or to control or cating and coughtang orcedures in the oral cavity. An electrical current passes through the tip of the blectrode into the tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.
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