The following data is part of a premarket notification filed by Sylvania Lighting Products with the FDA for Waldmann F85/100w Puva.
| Device ID | K852575 |
| 510k Number | K852575 |
| Device Name: | WALDMANN F85/100W PUVA |
| Classification | Cabinet, Phototherapy (puva) |
| Applicant | SYLVANIA LIGHTING PRODUCTS 100 ENDICOTT ST. Danvers, MA 01923 |
| Contact | Gwarren J Field |
| Correspondent | Gwarren J Field SYLVANIA LIGHTING PRODUCTS 100 ENDICOTT ST. Danvers, MA 01923 |
| Product Code | KGL |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-18 |
| Decision Date | 1985-08-16 |