The following data is part of a premarket notification filed by Medi-physics Inc. Dba Nycomed Amersham Imaging with the FDA for Echoseed/iodine-125 Seeds, Model 6733.
| Device ID | K010821 |
| 510k Number | K010821 |
| Device Name: | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING 3350 RIDGE AVE. Arlington Heights, IL 60004 |
| Contact | Subhash Patel |
| Correspondent | Subhash Patel MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING 3350 RIDGE AVE. Arlington Heights, IL 60004 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-19 |
| Decision Date | 2001-04-11 |