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FDA 510(k), K181439, SpyGlass DS and DS II Direct Visualization System
FDA 510(k), K181439, SpyGlass DS and DS II Direct Visualization System
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$89.00 USD
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510(K) Number: K181439
Device Name: SpyGlass DS and DS II 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: 06/01/2018
Decision Date: 08/23/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SpyGlass DS and DS II 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: 06/01/2018
Decision Date: 08/23/2018
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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