The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Hdr Iort Shielded Applicator.
| Device ID | K052351 |
| 510k Number | K052351 |
| Device Name: | HDR IORT SHIELDED APPLICATOR |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550 |
| Contact | Felix Mick |
| Correspondent | Felix Mick 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 | 2005-08-29 |
| Decision Date | 2005-10-17 |
| Summary: | summary |