The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Titanium Peg System.
| Device ID | K980822 |
| 510k Number | K980822 |
| Device Name: | TITANIUM PEG SYSTEM |
| Classification | Ocular Peg |
| Applicant | FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. Marshfield Hills, MA 02051 |
| Contact | Anne Bohsack |
| Correspondent | Anne Bohsack FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. Marshfield Hills, MA 02051 |
| Product Code | MQU |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1998-07-09 |