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510(k) Data Aggregation
(278 days)
UFR FIBEROPTIC CABLE
The UFR fiberoptic cable is Intended to transmit light for illumination purposes from light source to various instruments such as headlights, microscopes, endoscopes, etc. It is manufactured to the buyers' specifications and is intended for use with the buyers' existing equipment.
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The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a fiberoptic light cable. It outlines the regulatory approval process and includes the device's indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot provide the requested table and information based on the input text. The document focuses on regulatory approval based on substantial equivalence to existing devices, not on detailed performance study results.
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