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510(k) Data Aggregation
K Number
K142386Device Name
Operating Room Light Handle Adapter
Manufacturer
Litex Manufacturing, Inc.
Date Cleared
2014-09-29
(33 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
Litex Manufacturing, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Light Handle Adapters are permanent replacements to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and resterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the facility, through the light companies and other distributors.
Device Description
The Litex Manufacturing, Inc. Light Handle Adapter is a permanent replacement for the light manufacture's OEM reusable handle and it is designed to be permanently attached to the surgical light.
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