The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Ct Hdr Tandem/ring Applicator With Rectal Retractor Model 0407.
| Device ID | K122840 |
| 510k Number | K122840 |
| Device Name: | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550 |
| Contact | Chuck Smith |
| Correspondent | Chuck Smith MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. 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 | 2012-09-17 |
| Decision Date | 2012-12-14 |
| Summary: | summary |