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FDA 510(k), K143153, EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
FDA 510(k), K143153, EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
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$149.00 USD
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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
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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