The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Fci Mesh Wrapped Bioceramic Orbital Implant.
| Device ID | K023400 |
| 510k Number | K023400 |
| Device Name: | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT |
| Classification | Implant, Eye Sphere |
| 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 | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-09 |
| Decision Date | 2003-08-22 |