The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Iosert Lens Implant Instrument.
| Device ID | K854197 |
| 510k Number | K854197 |
| Device Name: | IOSERT LENS IMPLANT INSTRUMENT |
| Classification | Lens, Guide, Intraocular |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Contact | Helenihi |
| Correspondent | Helenihi CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1986-01-22 |