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510(k) Data Aggregation
K Number
K111342Device Name
LIGHT GUIDE CABLE
Manufacturer
SCHOTT NORTH AMERICA
Date Cleared
2011-11-25
(196 days)
Product Code
HBI
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
SCHOTT NORTH AMERICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Schott Light Guide Cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
Device Description
The Light guide cable consists of glass fibers which are glued or fused into ferrules on both ends. The ends are polished to effectively transmit light and are equipped with standard endoscope connectors to transmit visible light from the light source to the intended instrument. The fibers are covered by Silicone sheathing for ease of handling and protecting the fibers from damage. The device is intended to be Ethylene Oxide (EtO) sterilized by the user. Sterilization information is contained in section 14.
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