The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Eye Barrier.
| Device ID | K863182 |
| 510k Number | K863182 |
| Device Name: | EYE BARRIER |
| Classification | Frame, Spectacle |
| Applicant | O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
| Contact | Joe A Staley |
| Correspondent | Joe A Staley O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
| Product Code | HQZ |
| CFR Regulation Number | 886.5842 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-09-03 |