The following data is part of a premarket notification filed by Lee Pharmaceuticals with the FDA for Ultraviolet Rad-emitting Lamp.
| Device ID | K771077 |
| 510k Number | K771077 |
| Device Name: | ULTRAVIOLET RAD-EMITTING LAMP |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | LEE PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-06-15 |
| Decision Date | 1977-06-24 |