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FDA 510(k), K163058, Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
FDA 510(k), K163058, Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
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510(K) Number: K163058
Device Name: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Manufacturer: BOSTON SCIENTIFIC
Device Classification Name: endoscopic ultrasound system, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: ODG
Date Received: 11/01/2016
Decision Date: 01/30/2017
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Manufacturer: BOSTON SCIENTIFIC
Device Classification Name: endoscopic ultrasound system, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: ODG
Date Received: 11/01/2016
Decision Date: 01/30/2017
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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