510(k) K811726
K811726 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "LEKSELL STEREOACTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code LHF (Warmer, Microwave, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1981
- Date Received
- June 18, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Microwave, Infusion Fluid
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type