K033828 is an FDA 510(k) clearance for the CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Mick Radio-Nuclear Instruments, Inc. (Mt. Vernon, US). The FDA issued a Cleared decision on February 2, 2004, 54 days after receiving the submission on December 10, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K033828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2003 |
| Decision Date | February 02, 2004 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAQ — System, Applicator, Radionuclide, Remote-controlled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5700 |