The following data is part of a premarket notification filed by Sylvania Lighting Products with the FDA for Sylvania F8t5/puva & Waldmann F15t8/puva.
| Device ID | K852321 |
| 510k Number | K852321 |
| Device Name: | SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA |
| Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
| Applicant | SYLVANIA LIGHTING PRODUCTS 100 ENDICOTT ST. Danvers, MA 01923 |
| Contact | Warren J Field |
| Correspondent | Warren J Field SYLVANIA LIGHTING PRODUCTS 100 ENDICOTT ST. Danvers, MA 01923 |
| Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-30 |
| Decision Date | 1985-07-11 |