The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Ct/mr Compatible M.a.c. Interstitial Gyn Template.
| Device ID | K150979 |
| 510k Number | K150979 |
| Device Name: | CT/MR Compatible M.A.C. Interstitial GYN Template |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vermon, NY 10550 |
| Contact | Chuck Smith |
| Correspondent | Chuck Smith Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, NY 10550 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-13 |
| Decision Date | 2016-05-31 |
| Summary: | summary |