The following data is part of a premarket notification filed by Osram Gmbh with the FDA for Osram Uva Lamp.
| Device ID | K812853 |
| 510k Number | K812853 |
| Device Name: | OSRAM UVA LAMP |
| Classification | Lamp, Infrared, Non Heating |
| Applicant | OSRAM GMBH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IOB |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-13 |
| Decision Date | 1981-12-09 |