K042395 is an FDA 510(k) clearance for the OUTPATIENT III MINOR SURGERY LIGHT. This device is classified as a Light, Surgical, Ceiling Mounted (Class II — Special Controls, product code FSY).
Submitted by Burton Medical Products Corp. (Chatsworth, US). The FDA issued a Cleared decision on December 1, 2004, 90 days after receiving the submission on September 2, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K042395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2004 |
| Decision Date | December 01, 2004 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FSY — Light, Surgical, Ceiling Mounted |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |