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510(k) Data Aggregation

    K Number
    K961832
    Device Name
    BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
    Date Cleared
    1996-09-06

    (116 days)

    Product Code
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLUE RIDGE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device is to cover the laryngoscope blade and the top of the handle during endotracheal intubation to possibly reduce the cleaning time of the laryngoscope blade.
    Device Description
    This device is a molded plastic cover for a larvngoscope blade. It is made in two models, for either the Miller #2 or the MacIntosh #3 laryngoscope blade. Also, a portion of the device covers the upper portion of the laryngoscope handle. The device functions to cover the laryngoscope blade prior to use in the mouth. The device is made of a linear low density polycthylene copolymer, approved by the FDA, 21 CFR 177,1520, and is 1 mm thick. The master file number is #11624. It is made to conform to the laryngoscope blade. The cover adheres to the laryngoscope blade by a plastic clip that is formed from the plastic matcrial that encircles the top of the laryngoscope handle. It is a single use device
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