K092405 is an FDA 510(k) clearance for the MAMMOSITE MULTI LUMEN. This device is classified as a System, Applicator, Radionuclide, Remote-controlled (Class II - Special Controls, product code JAQ).
Submitted by Hologic, Inc. (Marlborough, US). The FDA issued a Cleared decision on August 27, 2009, 21 days after receiving the submission on August 6, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5700.
| 510(k) Number | K092405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | August 06, 2009 |
| Decision Date | August 27, 2009 |
| Days to Decision | 21 days |
| Submission Type | Special |
| 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 |