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510(k) Data Aggregation
K Number
K993089Device Name
DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
Manufacturer
Date Cleared
1999-10-14
(28 days)
Product Code
Regulation Number
878.4580Why 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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