The following data is part of a premarket notification filed by Medi-physics Inc. Dba Nycomed Amersham Imaging with the FDA for I-125 Seeds, Code: 6711.
| Device ID | K914281 |
| 510k Number | K914281 |
| Device Name: | I-125 SEEDS, CODE: 6711 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING 2636 S. CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Frank J Lyman |
| Correspondent | Frank J Lyman MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING 2636 S. CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-24 |
| Decision Date | 1991-11-22 |