The following data is part of a premarket notification filed by Mednext, Inc. with the FDA for Mednext Surgical Bur.
| Device ID | K970023 |
| 510k Number | K970023 |
| Device Name: | MEDNEXT SURGICAL BUR |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| 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 | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-03 |
| Decision Date | 1997-02-28 |