510(k) K852576
K852576 is an FDA 510(k) premarket notification submitted by Sylvania Lighting Products for the device "WALDMANN F85/100W UV6". The FDA issued a decision of Substantially Equivalent on July 11, 1985. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Sylvania Lighting Products has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1985
- Date Received
- June 18, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Ultraviolet, Dermatological
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type