The following data is part of a premarket notification filed by Global Eye Care, Inc. with the FDA for Dualenz Low Vision Eyewear.
| Device ID | K864594 |
| 510k Number | K864594 |
| Device Name: | DUALENZ LOW VISION EYEWEAR |
| Classification | Telescope, Spectacle, Low-vision |
| Applicant | GLOBAL EYE CARE, INC. 2133 BUFFALO RD. Rochester, NY 14624 |
| Contact | James C Bradford |
| Correspondent | James C Bradford GLOBAL EYE CARE, INC. 2133 BUFFALO RD. Rochester, NY 14624 |
| Product Code | HKK |
| CFR Regulation Number | 886.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-21 |
| Decision Date | 1987-01-20 |