The following data is part of a premarket notification filed by Visionex, Inc. with the FDA for Trabeculo-suprachoroidal Shunt.
| Device ID | K902296 |
| 510k Number | K902296 |
| Device Name: | TRABECULO-SUPRACHOROIDAL SHUNT |
| Classification | Implant, Eye Valve |
| Applicant | VISIONEX, INC. 1206 SARGENT DR. Sunnyvale, CA 94087 |
| Contact | Gin, Mba |
| Correspondent | Gin, Mba VISIONEX, INC. 1206 SARGENT DR. Sunnyvale, CA 94087 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-22 |
| Decision Date | 1991-03-14 |