The following data is part of a premarket notification filed by Onufryk Low Vision Ent. with the FDA for Modified Ophthalmic Opir Onufryk Image Deflector.
| Device ID | K900091 |
| 510k Number | K900091 |
| Device Name: | MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | ONUFRYK LOW VISION ENT. 9 WICKFORD WAY Fairport, NY 14450 |
| Contact | Michael Onufryk |
| Correspondent | Michael Onufryk ONUFRYK LOW VISION ENT. 9 WICKFORD WAY Fairport, NY 14450 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-05 |
| Decision Date | 1990-04-04 |