The following data is part of a premarket notification filed by Strato-ray Co. with the FDA for Model 6/01 Uv-b Fixture.
| Device ID | K904425 |
| 510k Number | K904425 |
| Device Name: | MODEL 6/01 UV-B FIXTURE |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | STRATO-RAY CO. 6500 WALKER ST. MINNEAPOLIS, MN 55426 |
| Contact | DONALD GUSTAFSON |
| Correspondent | DONALD GUSTAFSON STRATO-RAY CO. 6500 WALKER ST. MINNEAPOLIS, MN 55426 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-27 |
| Decision Date | 1990-11-21 |