The following data is part of a premarket notification filed by Nucletron B.v. with the FDA for Lumencare Azure Set F6, 150cm, Lumecare Azure Set 5f, 150 Cm, Lumencare Azure Set 5f, 140 Cm.
| Device ID | K132874 |
| 510k Number | K132874 |
| Device Name: | LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-13 |
| Decision Date | 2014-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213056770 | K132874 | 000 |
| 08717213056763 | K132874 | 000 |
| 08717213054332 | K132874 | 000 |
| 08717213055735 | K132874 | 000 |