The following data is part of a premarket notification filed by Braxx Biotech Co. Ltd with the FDA for “braxx” Esophageal Brachytherapy Applicator.
| Device ID | K183332 |
| 510k Number | K183332 |
| Device Name: | “BRAXX” Esophageal Brachytherapy Applicator |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | BRAXX Biotech Co. Ltd 6F., No.10, Songde Rd., Xinyi Dist Taipei City, TW 11076 |
| Contact | Judy Kao |
| Correspondent | Judy Kao BRAXX Biotech Co. Ltd 6F., No.10, Songde Rd., Xinyi Dist Taipei City, TW 11076 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-04-16 |