K904609 is an FDA 510(k) clearance for the XENON LIGHT SOURCE. This device is classified as a Illuminator, Fiberoptic, Surgical Field (Class II - Special Controls, product code HBI).
Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on December 18, 1990, 68 days after receiving the submission on October 11, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K904609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1990 |
| Decision Date | December 18, 1990 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HBI — Illuminator, Fiberoptic, Surgical Field |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |