The following data is part of a premarket notification filed by Midwest Eye Laboratories, Inc. with the FDA for Artificial Scleral Shell.
| Device ID | K904961 |
| 510k Number | K904961 |
| Device Name: | ARTIFICIAL SCLERAL SHELL |
| Classification | Shell, Scleral |
| Applicant | MIDWEST EYE LABORATORIES, INC. 9975 LYNDALE AVENUE SO. GETTYSBURG OFFICE CTR. #550 Minneapolis, MN 55420 |
| Contact | Michael Barrett |
| Correspondent | Michael Barrett MIDWEST EYE LABORATORIES, INC. 9975 LYNDALE AVENUE SO. GETTYSBURG OFFICE CTR. #550 Minneapolis, MN 55420 |
| Product Code | HQT |
| CFR Regulation Number | 886.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-05 |
| Decision Date | 1991-08-30 |