The following data is part of a premarket notification filed by Mri Devices Daum Gmbh with the FDA for Daum-lectric Mri Drilling Machine.
| Device ID | K021098 |
| 510k Number | K021098 |
| Device Name: | DAUM-LECTRIC MRI DRILLING MACHINE |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MRI DEVICES DAUM GMBH P.O. BOX 4331 Crofton,, MD 21114 |
| Contact | E. J Smith |
| Correspondent | E. J Smith MRI DEVICES DAUM GMBH P.O. BOX 4331 Crofton,, MD 21114 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-04 |
| Decision Date | 2002-12-03 |