The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Ct F/s/d Compatible Applicators (fletcher), Hdr Compatible Tandem And Ovoid Applicators (henschke), Hdr Ct Compatible Split Ring Applicator, Segmented Vaginal Applicator, Hdr Miami Applicator Hdr Brachytherapy Applicator, 2/3 Endometrial Applicator S.
| Device ID | K200221 |
| 510k Number | K200221 |
| Device Name: | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem And Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator S |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon, NY 10550 |
| Contact | James Hurlman |
| Correspondent | James Hurlman 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-29 |
| Decision Date | 2020-02-28 |