The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Surgical Eye Shield.
| Device ID | K781960 |
| 510k Number | K781960 |
| Device Name: | SURGICAL EYE SHIELD |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-21 |
| Decision Date | 1979-02-09 |