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510(k) Data Aggregation

    K Number
    K063380
    Device Name
    ECHOSTIM FACET TIP
    Manufacturer
    HAVEL'S, INC.
    Date Cleared
    2007-04-25

    (168 days)

    Product Code
    BSP, CAZ
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAVEL'S, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Havel's electrically insulated anesthesia conduction needles are used to puncture the tissue in order to gain entry and locally inject anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician to pinpoint the area of application.
    Device Description
    Drawings and a bill of materials for the EchoStim device are attached.
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