The following data is part of a premarket notification filed by Southwest Artificial Eyes, Inc. with the FDA for Scleral Shell.
| Device ID | K970327 |
| 510k Number | K970327 |
| Device Name: | SCLERAL SHELL |
| Classification | Shell, Scleral |
| Applicant | SOUTHWEST ARTIFICIAL EYES, INC. 4640 CENTERVIEW San Antonio, TX 78228 |
| Contact | Daniel M Wenske |
| Correspondent | Daniel M Wenske SOUTHWEST ARTIFICIAL EYES, INC. 4640 CENTERVIEW San Antonio, TX 78228 |
| Product Code | HQT |
| CFR Regulation Number | 886.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-28 |
| Decision Date | 1997-07-07 |