The following data is part of a premarket notification filed by Mednext, Inc. with the FDA for Mednext 1000 Drill.
| Device ID | K972308 |
| 510k Number | K972308 |
| Device Name: | MEDNEXT 1000 DRILL |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | MEDNEXT, INC. 5490 DEXTER WAY West Palm Beach, FL 33407 |
| Contact | Thomas J Mickel |
| Correspondent | Thomas J Mickel MEDNEXT, INC. 5490 DEXTER WAY West Palm Beach, FL 33407 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-20 |
| Decision Date | 1997-08-20 |