The following data is part of a premarket notification filed by Optonol, Ltd with the FDA for Express Mini Glaucoma Shunt.
| Device ID | K030350 |
| 510k Number | K030350 |
| Device Name: | EXPRESS MINI GLAUCOMA SHUNT |
| Classification | Implant, Eye Valve |
| Applicant | OPTONOL, LTD SURGICAL BUSINESS UNIT 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt OPTONOL, LTD SURGICAL BUSINESS UNIT 11460 JOHNS CREEK PARKWAY Duluth, GA 30097 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-03 |
| Decision Date | 2003-03-13 |
| Summary: | summary |