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510(k) Data Aggregation

    K Number
    K042555
    Device Name
    SURGICHIP TAG SURGICAL MARKER
    Manufacturer
    SURGICHIP, INC.
    Date Cleared
    2004-11-09

    (50 days)

    Product Code
    FZZ
    Regulation Number
    878.4660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICHIP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SURGICHIP Tag surgical marker is indicated to mark an anatomical site for surgery.
    Device Description
    The SURGICHIP™ Tag smart label and procedure that uses Radio Frequency Identification technology to mark an anatomical site prior to surgery. It is designed to be used in addition to the usual safeguards so that the correct procedure is performed on the correct site and on the intended patient.
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