The following data is part of a premarket notification filed by Fci Ophthalmics, Inc. with the FDA for Disposable Vitrectomy Sets, Disposable Virectomy Lenses.
| Device ID | K030054 |
| 510k Number | K030054 |
| Device Name: | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. Centerville, MA 02632 -2402 |
| Contact | Hillard Welch |
| Correspondent | Hillard Welch FCI OPHTHALMICS, INC. 344 ANNABELLE POINT RD. Centerville, MA 02632 -2402 |
| Product Code | HJK |
| Subsequent Product Code | HMX |
| Subsequent Product Code | HNN |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-06 |
| Decision Date | 2003-02-26 |