The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Microscope Mitts Support Tray Cover.
| Device ID | K842859 |
| 510k Number | K842859 |
| Device Name: | MICROSCOPE MITTS SUPPORT TRAY COVER |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1984-10-05 |