DiLumen C2 and Tool Mount — Lumendi, LLC (510(k) K211819)
DiLumen C2 and Tool Mount — Lumendi, LLC (510(k) K211819) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: DiLumen C2 and Tool Mount; Applicant: Lumendi, LLC; Clearance track: 510(k).
| Device name | DiLumen C2 and Tool Mount |
|---|---|
| Applicant | Lumendi, LLC |
| Clearance track | 510(k) |
| Submission number | K211819 |
| Decision | Substantially Equivalent |
| Decision date | 2021-10-22 |
| Date received | 2021-06-11 |
| Product code | FDF |
| Device class | 2 |
| Medical specialty | Gastroenterology, Urology |
| Applicant location | CT, US |
| Source | openFDA device |
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$1999/mo
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