The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Rare Earth Intra-ocular Magnet.
| Device ID | K860960 |
| 510k Number | K860960 |
| Device Name: | RARE EARTH INTRA-OCULAR MAGNET |
| Classification | Magnet, Permanent |
| Applicant | AMERITEK, INC. 9805 S.W. 132nd Court Miami, FL 33186 |
| Contact | Robert Galan |
| Correspondent | Robert Galan AMERITEK, INC. 9805 S.W. 132nd Court Miami, FL 33186 |
| Product Code | HPN |
| CFR Regulation Number | 886.4445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-13 |
| Decision Date | 1986-03-31 |