The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Xenon Light Source.
| Device ID | K904609 |
| 510k Number | K904609 |
| Device Name: | XENON LIGHT SOURCE |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1990-12-18 |