The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Dyonics Sterotoxic Positioner.
| Device ID | K790502 |
| 510k Number | K790502 |
| Device Name: | DYONICS STEROTOXIC POSITIONER |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | DYONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-13 |
| Decision Date | 1979-04-05 |