The following data is part of a premarket notification filed by Biolucent, Inc. with the FDA for Curay Custom Seed Array.
| Device ID | K053595 |
| 510k Number | K053595 |
| Device Name: | CURAY CUSTOM SEED ARRAY |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | BIOLUCENT, INC. 6 JOURNEY, SUITE 325 Aliso Viejo, CA 92656 |
| Contact | Sheryl Higgins |
| Correspondent | Sheryl Higgins BIOLUCENT, INC. 6 JOURNEY, SUITE 325 Aliso Viejo, CA 92656 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-23 |
| Decision Date | 2006-02-28 |
| Summary: | summary |