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FDA 510(k), K142556, Flexible Video-Uretero-Choledochoscope System
FDA 510(k), K142556, Flexible Video-Uretero-Choledochoscope System
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510(K) Number: K142556
Device Name: Flexible Video-Uretero-Choledochoscope System
Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
Device Classification Name: ureteroscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 09/11/2014
Decision Date: 10/23/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Flexible Video-Uretero-Choledochoscope System
Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
Device Classification Name: ureteroscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FGB
Date Received: 09/11/2014
Decision Date: 10/23/2014
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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