The following data is part of a premarket notification filed by International Isotopes, Inc. with the FDA for Imagyn 125 I Seed, Model Is 125.
| Device ID | K982421 |
| 510k Number | K982421 |
| Device Name: | IMAGYN 125 I SEED, MODEL IS 125 |
| Classification | Seed, Isotope, Gold, Titanium, Platinum |
| Applicant | INTERNATIONAL ISOTOPES, INC. 3100 JIM CHRISTAL RD. Denton, TX 76207 -2600 |
| Contact | Betsy C King |
| Correspondent | Betsy C King INTERNATIONAL ISOTOPES, INC. 3100 JIM CHRISTAL RD. Denton, TX 76207 -2600 |
| Product Code | IWG |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-07-31 |
| Summary: | summary |