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FDA 510(k) K143153, EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V, by Olympus Medical Systems Corp.

FDA 510(k) K143153, EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V, by Olympus Medical Systems Corp.

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510(K) Number: K143153
Device Name: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: duodenoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 11/03/2014
Decision Date: 01/15/2016
Regulation Medical Specialty: Gastroenterology/Urology
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