The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Self Retaining Bicanaliculus Intubation Set.
| Device ID | K041869 |
| 510k Number | K041869 |
| Device Name: | SELF RETAINING BICANALICULUS INTUBATION SET |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. Marshfield Hills, MA 02051 |
| Contact | Louis Armand |
| Correspondent | Louis Armand FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. Marshfield Hills, MA 02051 |
| 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 | 2004-07-09 |
| Decision Date | 2004-11-18 |