The following data is part of a premarket notification filed by Satelec with the FDA for Mini L.e.d. Oem Module.
| Device ID | K040808 |
| 510k Number | K040808 |
| Device Name: | MINI L.E.D. OEM MODULE |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Contact | Jackie Masse |
| Correspondent | Jackie Masse SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-04-28 |
| Summary: | summary |