K992090 is an FDA 510(k) clearance for the MILLENNIUM GOLD. This device is classified as a Light, Surgical, Ceiling Mounted (Class II - Special Controls, product code FSY).
Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 8, 1999, 79 days after receiving the submission on June 21, 1999.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K992090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1999 |
| Decision Date | September 08, 1999 |
| Days to Decision | 79 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 |