The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Mammosite Multi Lumen.
| Device ID | K092405 |
| 510k Number | K092405 |
| Device Name: | MAMMOSITE MULTI LUMEN |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01750 |
| Contact | Jennifer Sullivan |
| Correspondent | Jennifer Sullivan HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01750 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-06 |
| Decision Date | 2009-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25420045505053 | K092405 | 000 |
| 25420045505046 | K092405 | 000 |
| 25420045505039 | K092405 | 000 |
| 15420045505025 | K092405 | 000 |