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FDA 510(k), K183636, SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
FDA 510(k), K183636, SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
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$49.00 USD
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510(K) Number: K183636
Device Name: SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
Manufacturer: Boston Scientific Corporation
Device Classification Name: Choledochoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FBN
Date Received: 12/26/2018
Decision Date: 01/22/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
Manufacturer: Boston Scientific Corporation
Device Classification Name: Choledochoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FBN
Date Received: 12/26/2018
Decision Date: 01/22/2019
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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