The following data is part of a premarket notification filed by Chiron Intraoptics with the FDA for Optisol-gs Corneal Storage Media.
| Device ID | K924165 |
| 510k Number | K924165 |
| Device Name: | OPTISOL-GS CORNEAL STORAGE MEDIA |
| 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 | 1992-08-19 |
| Decision Date | 1992-10-06 |