The following data is part of a premarket notification filed by Epic Medical Concepts & Innovations with the FDA for Flexi-lume Led System.
| Device ID | K140281 |
| 510k Number | K140281 |
| Device Name: | FLEXI-LUME LED SYSTEM |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | EPIC MEDICAL CONCEPTS & INNOVATIONS 6950 SQUIBB RD, STE 300 Mission, KS 66202 |
| Contact | Alex Waller |
| Correspondent | Alex Waller EPIC MEDICAL CONCEPTS & INNOVATIONS 6950 SQUIBB RD, STE 300 Mission, KS 66202 |
| Product Code | EBZ |
| Subsequent Product Code | EAY |
| Subsequent Product Code | EEG |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-04 |
| Decision Date | 2014-07-24 |
| Summary: | summary |