The following data is part of a premarket notification filed by Mednext, Inc. with the FDA for Mednext Bur.
| Device ID | K935584 |
| 510k Number | K935584 |
| Device Name: | MEDNEXT BUR |
| Classification | Bur, Ear, Nose And Throat |
| Applicant | MEDNEXT, INC. 3878 PROSPECT AVENUE, SUITE 24 West Point Beach, FL 33404 |
| Contact | Thomas J Mickel, Ph.d. |
| Correspondent | Thomas J Mickel, Ph.d. MEDNEXT, INC. 3878 PROSPECT AVENUE, SUITE 24 West Point Beach, FL 33404 |
| Product Code | EQJ |
| CFR Regulation Number | 874.4140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-02-22 |