The following data is part of a premarket notification filed by Hydron Pty Limited with the FDA for Alphasphere Orbital Implant.
| Device ID | K053298 |
| 510k Number | K053298 |
| Device Name: | ALPHASPHERE ORBITAL IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | HYDRON PTY LIMITED 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon HYDRON PTY LIMITED 733 BOLSANA DRIVE Laguna Beach, CA 92651 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-25 |
| Decision Date | 2006-05-09 |
| Summary: | summary |