The following data is part of a premarket notification filed by Richard James, Inc. with the FDA for Parel Rare Earth Magnet, I.o.m., Intraocular Mag.
| Device ID | K880855 |
| 510k Number | K880855 |
| Device Name: | PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG |
| Classification | Magnet, Permanent |
| Applicant | RICHARD JAMES, INC. P.O. BOX 309 Lynnfield, MA 01940 |
| Contact | Wayne A Richard |
| Correspondent | Wayne A Richard RICHARD JAMES, INC. P.O. BOX 309 Lynnfield, MA 01940 |
| Product Code | HPN |
| CFR Regulation Number | 886.4445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-04-01 |