The following data is part of a premarket notification filed by Nucletron B.v. with the FDA for Fletcher Ct/mr Shielded Applicator Set (6 Mm) Fletcher Ct/mr Shielded Applicator Set (4 Mm).
| Device ID | K132889 |
| 510k Number | K132889 |
| Device Name: | FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 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 | 2013-09-16 |
| Decision Date | 2014-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213024441 | K132889 | 000 |
| 08717213024298 | K132889 | 000 |
| 08717213014121 | K132889 | 000 |
| 08717213024342 | K132889 | 000 |