The following data is part of a premarket notification filed by Optimed, Inc. with the FDA for Optimed Glaucoma Pressure Regulator.
| Device ID | K903462 |
| 510k Number | K903462 |
| Device Name: | OPTIMED GLAUCOMA PRESSURE REGULATOR |
| Classification | Implant, Eye Valve |
| Applicant | OPTIMED, INC. 126 POWER AVE. Santa Barbara, CA 93103 |
| Contact | Myron Lippman |
| Correspondent | Myron Lippman OPTIMED, INC. 126 POWER AVE. Santa Barbara, CA 93103 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-01 |
| Decision Date | 1990-10-16 |