The following data is part of a premarket notification filed by Advanced Radiation Therapy, Llc with the FDA for Art Shielded Breast Applicator.
| Device ID | K062135 |
| 510k Number | K062135 |
| Device Name: | ART SHIELDED BREAST APPLICATOR |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | ADVANCED RADIATION THERAPY, LLC 9 LINNELL CIRCLE Billerica, MA 01820 |
| Contact | Raymond J Bricault |
| Correspondent | Raymond J 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 | 2006-07-26 |
| Decision Date | 2006-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850306007506 | K062135 | 000 |
| 00850306007124 | K062135 | 000 |
| 00850306007131 | K062135 | 000 |
| 00850306007148 | K062135 | 000 |
| 00850306007155 | K062135 | 000 |
| 00850306007162 | K062135 | 000 |
| 00850306007179 | K062135 | 000 |
| 00850306007186 | K062135 | 000 |
| 00850306007193 | K062135 | 000 |
| 00850306007117 | K062135 | 000 |
| 00850306007100 | K062135 | 000 |
| 00850306007018 | K062135 | 000 |
| 00850306007025 | K062135 | 000 |
| 00850306007049 | K062135 | 000 |
| 00850306007056 | K062135 | 000 |
| 00850306007063 | K062135 | 000 |
| 00850306007070 | K062135 | 000 |
| 00850306007087 | K062135 | 000 |
| 00850306007094 | K062135 | 000 |
| 00850306007216 | K062135 | 000 |
| 00850306007223 | K062135 | 000 |
| 00850306007421 | K062135 | 000 |
| 00850306007438 | K062135 | 000 |
| 00850306007445 | K062135 | 000 |
| 00850306007452 | K062135 | 000 |
| 00850306007469 | K062135 | 000 |
| 00850306007476 | K062135 | 000 |
| 00850306007483 | K062135 | 000 |
| 00850306007490 | K062135 | 000 |
| 00850306007414 | K062135 | 000 |
| 00850306007407 | K062135 | 000 |
| 00850306007230 | K062135 | 000 |
| 00850306007247 | K062135 | 000 |
| 00850306007254 | K062135 | 000 |
| 00850306007261 | K062135 | 000 |
| 00850306007278 | K062135 | 000 |
| 00850306007285 | K062135 | 000 |
| 00850306007292 | K062135 | 000 |
| 00850306007308 | K062135 | 000 |
| 00850306007001 | K062135 | 000 |