The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Dyonics Drill Guide/isometer System.
| Device ID | K880739 |
| 510k Number | K880739 |
| Device Name: | DYONICS DRILL GUIDE/ISOMETER SYSTEM |
| Classification | Guide, Drill, Ligament |
| Applicant | DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Kenneth E Carrier |
| Correspondent | Kenneth E Carrier DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | LXI |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-24 |
| Decision Date | 1988-03-21 |