The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Iolab Lacrimal Duct Catheter.
| Device ID | K935233 |
| 510k Number | K935233 |
| Device Name: | IOLAB LACRIMAL DUCT CATHETER |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Contact | Susan H Caballa |
| Correspondent | Susan H Caballa CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-09-15 |
| Summary: | summary |