The following data is part of a premarket notification filed by Gulden Ophthalmics with the FDA for Eye Sphere, Conformers.
| Device ID | K972661 |
| 510k Number | K972661 |
| Device Name: | EYE SPHERE, CONFORMERS |
| Classification | Implant, Eye Sphere |
| Applicant | GULDEN OPHTHALMICS 225 CADWALADER AVE. Elkins Park, PA 19027 -2020 |
| Contact | Thomas Cockley |
| Correspondent | Thomas Cockley GULDEN OPHTHALMICS 225 CADWALADER AVE. Elkins Park, PA 19027 -2020 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-16 |
| Decision Date | 1997-10-03 |
| Summary: | summary |