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510(k) Data Aggregation

    K Number
    K993089
    Device Name
    DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
    Date Cleared
    1999-10-14

    (28 days)

    Product Code
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEROYAL CARDIOVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DeRoyal Disposable Rigid Light Handle and Adapter are indicated for use as accessories to a surgical lamp. The adapter is to be used, when necessary, to attach the light handle to the surgical lamp. The light handle is to be used to position the light without contaminating the gloved hand.
    Device Description
    The DeRoyal Disposable Rigid Light Handle and Adapter function in the same manner as predicate devices in that they are intended to be used as accessories to a surgical lamp which are used to position the light for illumination in various areas of the surgical field. The DeRoyal Disposable Rigid Light Handle and Adapter are made of materials commonly used for their purposes. The light handle contains a protective shield at the base which is used to prevent the gloved hand from contaminated surfaces. The protective shield may be folded and attached to the light handle to reduce space needed for packaging and storage.
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