The following data is part of a premarket notification filed by Kronner Medical with the FDA for Kronner Spherical Cutters.
| Device ID | K894228 |
| 510k Number | K894228 |
| Device Name: | KRONNER SPHERICAL CUTTERS |
| Classification | Template |
| Applicant | KRONNER MEDICAL 544 WEST UMPQUA SUITE 104 Roseburg, OR 97470 |
| Product Code | HWT |
| CFR Regulation Number | 888.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1990-07-23 |