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510(k) Data Aggregation

    K Number
    K142386
    Device Name
    Operating Room Light Handle Adapter
    Manufacturer
    Litex Manufacturing, Inc.
    Date Cleared
    2014-09-29

    (33 days)

    Product Code
    FTA
    Regulation Number
    878.4580
    Why 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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