The following data is part of a premarket notification filed by Mcghan Medical Corp. with the FDA for Implant, Eye Sphere.
| Device ID | K781356 |
| 510k Number | K781356 |
| Device Name: | IMPLANT, EYE SPHERE |
| Classification | Implant, Eye Sphere |
| Applicant | MCGHAN MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-07 |
| Decision Date | 1978-08-21 |