The following data is part of a premarket notification filed by Osram Gmbh with the FDA for Osram Ultramed 400 W.
| Device ID | K863937 |
| 510k Number | K863937 |
| Device Name: | OSRAM ULTRAMED 400 W |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | OSRAM GMBH POSTFACH 90 06 20 D-8000 MUNCHEN 90 West Germany, DE |
| Contact | Dobiasch |
| Correspondent | Dobiasch OSRAM GMBH POSTFACH 90 06 20 D-8000 MUNCHEN 90 West Germany, DE |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-09 |
| Decision Date | 1986-11-04 |