The following data is part of a premarket notification filed by Miami Eye Technology, Inc. with the FDA for Rare-earth Intra-ocular Magnet.
| Device ID | K831702 |
| 510k Number | K831702 |
| Device Name: | RARE-EARTH INTRA-OCULAR MAGNET |
| Classification | Magnet, Permanent |
| Applicant | MIAMI EYE TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HPN |
| CFR Regulation Number | 886.4445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-25 |
| Decision Date | 1983-06-30 |