510(k) K863937
K863937 is an FDA 510(k) premarket notification submitted by Osram GmbH for the device "OSRAM ULTRAMED 400 W". The FDA issued a decision of SN on November 4, 1986. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Osram GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- November 4, 1986
- Date Received
- October 9, 1986
- 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