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510(k) Data Aggregation

    K Number
    K113247
    Device Name
    ANESTHESIA INJECTION TOOL SET
    Manufacturer
    KI WORKS CO., LTD.
    Date Cleared
    2012-03-27

    (146 days)

    Product Code
    EJI
    Regulation Number
    872.6770
    Why did this record match?
    Applicant Name (Manufacturer) :

    KI WORKS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures.
    Device Description
    KI works' Anesthesia Injection Tool Set (KIW-1000) is a device for injecting local anesthetic for anesthesia prior to, or in conjunction with, dental procedures. This device consists of Main body, Hand-piece, Battery pack and Adapter. All operating displays and the majority of the operator controls are located on front panel of the control unit.
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