The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Mono-crawford Naso-lacrimal Intubation Device.
| Device ID | K061404 |
| 510k Number | K061404 |
| Device Name: | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. Centerville, MA 02632 -2402 |
| Contact | Hillard W Welch |
| Correspondent | Hillard W Welch FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. Centerville, MA 02632 -2402 |
| 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 | 2006-05-19 |
| Decision Date | 2006-08-07 |