The following data is part of a premarket notification filed by Mednet Locator, Inc. with the FDA for Ultrabur.
| Device ID | K974174 |
| 510k Number | K974174 |
| Device Name: | ULTRABUR |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MEDNET LOCATOR, INC. 7000 SHADOW OAKS Memphis, TN 38125 |
| Contact | Judy Chandleer |
| Correspondent | Judy Chandleer MEDNET LOCATOR, INC. 7000 SHADOW OAKS Memphis, TN 38125 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-06 |
| Decision Date | 1998-03-10 |