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FDA 510(k), K173317, DiLumen C2; DiLumen Tool Mount
FDA 510(k), K173317, DiLumen C2; DiLumen Tool Mount
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$149.00 USD
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510(K) Number: K173317
Device Name: DiLumen C2; DiLumen Tool Mount
Manufacturer: Lumendi, LLC
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 10/19/2017
Decision Date: 04/17/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DiLumen C2; DiLumen Tool Mount
Manufacturer: Lumendi, LLC
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 10/19/2017
Decision Date: 04/17/2018
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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