The following data is part of a premarket notification filed by Lumendi, Llc with the FDA for Dilumen C2; Dilumen Tool Mount.
| Device ID | K173317 |
| 510k Number | K173317 |
| Device Name: | DiLumen C2; DiLumen 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 553 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 | 2017-10-19 |
| Decision Date | 2018-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10865309000246 | K173317 | 000 |
| 10858836007031 | K173317 | 000 |
| 10858836007024 | K173317 | 000 |
| 00858836007003 | K173317 | 000 |
| 00858836007089 | K173317 | 000 |
| 00858836007065 | K173317 | 000 |