The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Optical Zone/hexagonal/astigmatism/radial Markers.
| Device ID | K925606 |
| 510k Number | K925606 |
| Device Name: | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS |
| Classification | Marker, Ocular |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Contact | Carol L Patterson |
| Correspondent | Carol L Patterson CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | HMR |
| CFR Regulation Number | 886.4570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1994-08-29 |