The following data is part of a premarket notification filed by Nucletron with the FDA for Vaginal Ct / Mr Multi Channel Applicator Set.
| Device ID | K111973 |
| 510k Number | K111973 |
| Device Name: | VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | NUCLETRON 7021 COLUMBIA GATEWAY DR SUITE 200 Columbia, MD 21046 |
| Contact | Michael Paul |
| Correspondent | Michael Paul NUCLETRON 7021 COLUMBIA GATEWAY DR SUITE 200 Columbia, MD 21046 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-12 |
| Decision Date | 2011-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717213013919 | K111973 | 000 |
| 08717213013902 | K111973 | 000 |
| 08717213013896 | K111973 | 000 |
| 08717213013889 | K111973 | 000 |
| 08717213054356 | K111973 | 000 |
| 08717213056817 | K111973 | 000 |