The following data is part of a premarket notification filed by Nucletron B.v. with the FDA for Henschke Titanium Applicator Set.
| Device ID | K151272 |
| 510k Number | K151272 |
| Device Name: | Henschke Titanium Applicator Set |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON B.V. WAARDGELDER 1 Veenendaal, NL 3905 Th |
| Contact | Lizette Van De Streek |
| Correspondent | Lizette Van De Streek 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 | 2015-05-13 |
| Decision Date | 2015-06-23 |
| Summary: | summary |