The following data is part of a premarket notification filed by Anjon Holdings Llc with the FDA for Anjon Bremer Halo System.
| Device ID | K193256 |
| 510k Number | K193256 |
| Device Name: | Anjon Bremer Halo System |
| Classification | Component, Traction, Invasive |
| Applicant | Anjon Holdings LLC 4801 Dawin Road Jacksonville, FL 32207 |
| Contact | Kenneth A Collins |
| Correspondent | Kenneth A Collins Anjon Holdings LLC 4801 Dawin Road Jacksonville, FL 32207 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-03-02 |