The following data is part of a premarket notification filed by Uromed Corp. with the FDA for Uromed Brachytheraphy Iodine-125 Sources.
| Device ID | K982226 |
| 510k Number | K982226 |
| Device Name: | UROMED BRACHYTHERAPHY IODINE-125 SOURCES |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | UROMED CORP. 64 A ST. Needham, MA 02194 |
| Contact | Frederick Tobia |
| Correspondent | Frederick Tobia UROMED CORP. 64 A ST. Needham, MA 02194 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-24 |
| Decision Date | 1999-05-13 |
| Summary: | summary |