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510(k) Data Aggregation

    K Number
    K032970
    Device Name
    ACRA-CUT XPRESS 120
    Manufacturer
    ACRA CUT, INC.
    Date Cleared
    2003-12-08

    (76 days)

    Product Code
    HBF
    Regulation Number
    882.4305
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACRA CUT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes. The device does not assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure rest firmly with the surgeon.
    Device Description
    The ACRA-CUT XPRESS 120 is a battery operated drill that has a skull perforator permanently attached to it. It is for one time use and is delivered charged and sterile.
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