The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Contura Multi-lumen Balloon Source Applicator For Brachytherapy, Models B001-45 And B011-45.
| Device ID | K080791 |
| 510k Number | K080791 |
| Device Name: | CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | SENORX, INC. 11 COLUMBIA Aliso Viejo, CA 92656 |
| Contact | Eben Gordon |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-03-20 |
| Decision Date | 2008-04-30 |
| Summary: | summary |