510(k) K812853
K812853 is an FDA 510(k) premarket notification submitted by Osram GmbH for the device "OSRAM UVA LAMP". The FDA issued a decision of Substantially Equivalent on December 9, 1981. The device falls under product code IOB (Lamp, Infrared, Non Heating), a Class II device regulated under 21 CFR 890.5500. Osram GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1981
- Date Received
- October 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Non Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type