The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Light Source, Endoscop, Xenon Arc.
| Device ID | K890448 |
| 510k Number | K890448 |
| Device Name: | LIGHT SOURCE, ENDOSCOP, XENON ARC |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Contact | Roger R O'brien |
| Correspondent | Roger R O'brien MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-05-08 |