510(k) K882333
K882333 is an FDA 510(k) premarket notification submitted by Commercial Products & Engineering Co. for the device "FLOOR LIGHT". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Commercial Products & Engineering Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1988
- Date Received
- June 6, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Floor Standing
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type