The following data is part of a premarket notification filed by S. Jackson, Inc. with the FDA for Eye Muscle Sleeves.
| Device ID | K831726 |
| 510k Number | K831726 |
| Device Name: | EYE MUSCLE SLEEVES |
| Classification | Mesh, Surgical |
| Applicant | S. JACKSON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-31 |
| Decision Date | 1983-08-11 |