The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Seed Selectron Model V. 1.0.
| Device ID | K010032 |
| 510k Number | K010032 |
| Device Name: | SEED SELECTRON MODEL V. 1.0 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Contact | Ralph E Shuping |
| Correspondent | Ralph E Shuping NUCLETRON CORP. 7080 COLUMBIA GATEWAY DR. Columbia, MD 21046 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-03 |
| Decision Date | 2001-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213018679 | K010032 | 000 |
| 08717213024113 | K010032 | 000 |
| 08717213024106 | K010032 | 000 |
| 08717213030473 | K010032 | 000 |
| 08717213023949 | K010032 | 000 |
| 08717213023932 | K010032 | 000 |
| 08717213023925 | K010032 | 000 |
| 08717213018693 | K010032 | 000 |