The following data is part of a premarket notification filed by Nucletron Bv with the FDA for Martinez Prostate Template Set.
| Device ID | K142439 |
| 510k Number | K142439 |
| Device Name: | Martinez Prostate Template Set |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Nucletron BV Waardgelder 1 Veenendaal, NL 3905 Th |
| Contact | Rudolf Vos |
| Correspondent | Rudolf Vos Nucletron BV Waardgelder 1 Veenendaal, NL 3905 Th |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-29 |
| Decision Date | 2015-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213031951 | K142439 | 000 |
| 08717213031913 | K142439 | 000 |
| 08717213055179 | K142439 | 000 |
| 08717213055162 | K142439 | 000 |
| 08717213055155 | K142439 | 000 |
| 08717213055148 | K142439 | 000 |
| 08717213054936 | K142439 | 000 |