The following data is part of a premarket notification filed by Bremer Orthopedics with the FDA for Bremer Halo System.
| Device ID | K864746 |
| 510k Number | K864746 |
| Device Name: | BREMER HALO SYSTEM |
| Classification | Tong, Skull For Traction |
| Applicant | BREMER ORTHOPEDICS 433 MARGARET ST. Jacksonville, FL 32204 |
| Contact | Paul W Bremer |
| Correspondent | Paul W Bremer BREMER ORTHOPEDICS 433 MARGARET ST. Jacksonville, FL 32204 |
| Product Code | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-05 |
| Decision Date | 1986-12-22 |