The following data is part of a premarket notification filed by Chiron Ophthalmics with the FDA for Chiroflex Lens Microsert.
| Device ID | K903574 |
| 510k Number | K903574 |
| Device Name: | CHIROFLEX LENS MICROSERT |
| Classification | Lens, Guide, Intraocular |
| Applicant | CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Contact | Mcjarvey |
| Correspondent | Mcjarvey CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-08 |
| Decision Date | 1990-09-17 |