The following data is part of a premarket notification filed by Lumendi, Llc with the FDA for Dilumen C2 And Tool Mount.
| Device ID | K211819 |
| 510k Number | K211819 |
| Device Name: | DiLumen C2 And Tool Mount |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Lumendi, LLC 253 Post Road West Westport, CT 06880 |
| Contact | Dennis Daniels |
| Correspondent | John J Smith Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-11 |
| Decision Date | 2021-10-22 |