The following data is part of a premarket notification filed by Biolucent, Inc. with the FDA for Biolucent Applicator, Model Rta-xx.
| Device ID | K061241 |
| 510k Number | K061241 |
| Device Name: | BIOLUCENT APPLICATOR, MODEL RTA-XX |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | BIOLUCENT, INC. 6 JOURNEY, SUITE 325 Aliso Viejo, CA 92656 |
| Contact | J. David Campbell |
| Correspondent | J. David Campbell BIOLUCENT, INC. 6 JOURNEY, SUITE 325 Aliso Viejo, CA 92656 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-03 |
| Decision Date | 2006-07-28 |
| Summary: | summary |