510(k) K802140
K802140 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "LEKSELL STEREOTACTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on February 5, 1981. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1981
- Date Received
- September 4, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Head, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1920
- Review Panel
- RA
- Submission Type