The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Spherex Implant.
| Device ID | K962241 |
| 510k Number | K962241 |
| Device Name: | GORE SPHEREX IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | John W Nicholson |
| Correspondent | John W Nicholson W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-11 |
| Decision Date | 1996-08-22 |
| Summary: | summary |