The following data is part of a premarket notification filed by Chiron Ophthalmics with the FDA for Chiroflex Ii Lens Microsert(tm).
| Device ID | K914311 |
| 510k Number | K914311 |
| Device Name: | CHIROFLEX II LENS MICROSERT(TM) |
| Classification | Intraocular Lens |
| Applicant | CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Contact | Carol L Patterson |
| Correspondent | Carol L Patterson CHIRON OPHTHALMICS 9342 JERONIMO RD. Irvine, CA 92718 |
| Product Code | HQL |
| CFR Regulation Number | 886.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-26 |
| Decision Date | 1992-01-27 |