FDA 510(k), K210851, DiLumen Endolumenal Interventional Platform (DiLumen)
FDA 510(k), K210851, DiLumen Endolumenal Interventional Platform (DiLumen)
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K210851
Device Name: DiLumen Endolumenal Interventional Platform (DiLumen)
Manufacturer: Dennis Daniels
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
Regulation Number: FDF
Classification Product Code: 03/22/2021
Date Received: 04/21/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: DiLumen Endolumenal Interventional Platform (DiLumen)
Manufacturer: Dennis Daniels
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
Regulation Number: FDF
Classification Product Code: 03/22/2021
Date Received: 04/21/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
- 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.
View full details