The following data is part of a premarket notification filed by Mednext, Inc. with the FDA for Mednext Micro-drill.
| Device ID | K943108 |
| 510k Number | K943108 |
| Device Name: | MEDNEXT MICRO-DRILL |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MEDNEXT, INC. 2000 AVENUE "P", SUITE 8 Riviera Beach, FL 33404 |
| Contact | Thomas J Mickel, Ph.d. |
| Correspondent | Thomas J Mickel, Ph.d. MEDNEXT, INC. 2000 AVENUE "P", SUITE 8 Riviera Beach, FL 33404 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-29 |
| Decision Date | 1994-08-17 |