510(k) K852321
- Device
- SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA
- Applicant
- SYLVANIA LIGHTING PRODUCTS
- 510(k) number
- K852321
- 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 &
- Decision
- Substantially Equivalent - With Drug (SESD)
- Decision date
- 1985-07-11
- Date received
- 1985-05-30
- Regulation
- 510(k) Premarket Notification
- Classification name
- 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
- Medical specialty
- 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
- Review panel
- General & Plastic Surgery
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WARREN J FIELD
- Address
- 100 Endicott St. Danvers MA US 01923 01923
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases