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FDA 510(k) K142922, SpyGlass DS Direct Visualization System, by Boston Scientific Corporation

FDA 510(k) K142922, SpyGlass DS Direct Visualization System, by Boston Scientific Corporation

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510(K) Number: K142922
Device Name: SpyGlass DS Direct Visualization System
Manufacturer: Boston Scientific Corporation
Device Classification Name: choledochoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FBN
Date Received: 10/08/2014
Decision Date: 01/16/2015
Regulation Medical Specialty: Gastroenterology/Urology
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