FDA 510(k), K181451, URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
FDA 510(k), K181451, URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
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510(K) Number: K181451
Device Name: URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: Ureteroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 06/01/2018
Decision Date: 01/16/2019
Regulation Medical Specialty: Gastroenterology/Urology
785 pages (1,793 of 2,578 original pages are fully redacted)