The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Curietron 192 High Dose Rate.
| Device ID | K890799 |
| 510k Number | K890799 |
| Device Name: | CURIETRON 192 HIGH DOSE RATE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | CIS-US, INC. 10 DE ANGELO DR. Bedford, MA 01730 |
| Contact | Rita T Mccullough |
| Correspondent | Rita T Mccullough CIS-US, INC. 10 DE ANGELO DR. Bedford, MA 01730 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-17 |
| Decision Date | 1989-10-27 |