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FDA 510(k), K162428, DiLumen Endolumenal Interventional Platform
FDA 510(k), K162428, DiLumen Endolumenal Interventional Platform
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510(K) Number: K162428
Device Name: DiLumen Endolumenal Interventional Platform
Manufacturer: Lumendi, LLC
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 08/30/2016
Decision Date: 12/06/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DiLumen Endolumenal Interventional Platform
Manufacturer: Lumendi, LLC
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 08/30/2016
Decision Date: 12/06/2016
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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