The following data is part of a premarket notification filed by Bremer Medical, Inc. with the FDA for Bremer Halo System Cervical Traction Skull Pin.
| Device ID | K915800 |
| 510k Number | K915800 |
| Device Name: | BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN |
| Classification | Component, Traction, Invasive |
| Applicant | BREMER MEDICAL, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan BREMER MEDICAL, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-03-16 |