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510(k) Data Aggregation

    K Number
    K031207
    Device Name
    SAFETY RELEASE ARCH BAR KIT
    Manufacturer
    CASEY SURGICAL, LLC
    Date Cleared
    2003-07-15

    (90 days)

    Product Code
    DYX
    Regulation Number
    872.4600
    Why did this record match?
    Applicant Name (Manufacturer) :

    CASEY SURGICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Casey Surgical Safety Release ™ Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.
    Device Description
    The Casey Surgical Safety Release ™ Arch Bar Kit is made of four components which are installed by an oral surgeon or dentist along with ligature wires. The installed device provides temporary jaw immobilization. The device incorporates a safety release mechanism.
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