The following data is part of a premarket notification filed by Nucletron B.v. with the FDA for Luneray;catheter 6f 50cm, Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm R75 Mm.
| Device ID | K140803 |
| 510k Number | K140803 |
| Device Name: | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON B.V. WAARDGELDER 1 Veenendaal, NL 3905 Th |
| Contact | Rudolf Vos |
| Correspondent | Rudolf Vos NUCLETRON B.V. 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 | 2014-03-31 |
| Decision Date | 2014-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213054394 | K140803 | 000 |
| 08717213054387 | K140803 | 000 |
| 08717213054370 | K140803 | 000 |
| 08717213054363 | K140803 | 000 |