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510(k) Data Aggregation

    K Number
    K992898
    Device Name
    THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
    Manufacturer
    BRIGHT MEDICAL INSTRUMENTS
    Date Cleared
    1999-10-21

    (55 days)

    Product Code
    GZT
    Regulation Number
    882.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRIGHT MEDICAL INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provide a self-locking device to hold the edges of a wound open for neurosurgical procedures.
    Device Description
    Series of dilators, tubular retractors of various lengths and guide wire for use in providing access to the spine for minimally invasive discectomy procedures.
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