The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Select Seed I-125.
| Device ID | K002429 |
| 510k Number | K002429 |
| Device Name: | SELECT SEED I-125 |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Robert Applebaum |
| Correspondent | Robert Applebaum NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2001-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 98717213037840 | K002429 | 000 |
| 98717213037833 | K002429 | 000 |
| 08717213037854 | K002429 | 000 |