The following data is part of a premarket notification filed by Bremer Medical, Inc. with the FDA for Bremer Imaging Tongs-mri Model.
| Device ID | K924606 |
| 510k Number | K924606 |
| Device Name: | BREMER IMAGING TONGS-MRI MODEL |
| Classification | Tong, Skull For Traction |
| 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 | HAX |
| CFR Regulation Number | 882.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-11 |
| Decision Date | 1993-09-09 |