The following data is part of a premarket notification filed by Advanced Radiation Therapy, Llc with the FDA for Art Brachytherapy Applicator.
| Device ID | K060299 |
| 510k Number | K060299 |
| Device Name: | ART BRACHYTHERAPY APPLICATOR |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | ADVANCED RADIATION THERAPY, LLC 9 LINNELL CIRCLE Billerica, MA 01820 |
| Contact | Raymond Bricault |
| Correspondent | Raymond Bricault ADVANCED RADIATION THERAPY, LLC 9 LINNELL CIRCLE Billerica, MA 01820 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2006-06-06 |
| Summary: | summary |