The following data is part of a premarket notification filed by Chiron Intraoptics with the FDA for Optisol Corneal Storage Media Container/modified.
| Device ID | K921729 |
| 510k Number | K921729 |
| Device Name: | OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED |
| Classification | Media, Corneal Storage |
| Applicant | CHIRON INTRAOPTICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Contact | Carol L Patterson |
| Correspondent | Carol L Patterson CHIRON INTRAOPTICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Product Code | LYX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-25 |
| Decision Date | 1992-06-09 |