The following data is part of a premarket notification filed by Nucletron Corp. with the FDA for Intracavitary Mould Applicator Set, Model 189.001.
| Device ID | K041715 |
| 510k Number | K041715 |
| Device Name: | INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON CORP. 8671 ROBERT FULTON DRIVE Columbia, MD 21046 -2133 |
| Contact | Lisa Dimmick |
| Correspondent | Lisa Dimmick NUCLETRON CORP. 8671 ROBERT FULTON DRIVE Columbia, MD 21046 -2133 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-23 |
| Decision Date | 2005-03-24 |
| Summary: | summary |