510(k) K810207
K810207 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "MINOR SURGERY LIGHT". The FDA issued a decision of Substantially Equivalent on February 13, 1981. The device falls under product code GBC (Lamp, Surgical, Incandescent), a Class II device regulated under 21 CFR 878.4580. Cavitron Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1981
- Date Received
- January 26, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Surgical, Incandescent
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type