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FDA 510(k), K143556, Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
FDA 510(k), K143556, Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
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510(K) Number: K143556
Device Name: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
Manufacturer: MARY MOORE
Device Classification Name: Enteroscope And Accessories
Regulation Number: FDA
Classification Product Code: 12/15/2014
Date Received: 08/20/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
Manufacturer: MARY MOORE
Device Classification Name: Enteroscope And Accessories
Regulation Number: FDA
Classification Product Code: 12/15/2014
Date Received: 08/20/2015
Decision Date: Substantially Equivalent (SESE)
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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