510(k) K828670
- Device
- UVATEC SUNTAMED 400
- Applicant
- SOLITEC GMBH
- 510(k) number
- K828670
- 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 (SESE)
- Decision date
- 1983-01-17
- Date received
- 1982-11-30
- 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
- Radiology
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- Fraunhoferstrasse 5 Planegg DE D-82152 D-82152
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