The following data is part of a premarket notification filed by Diros Technology Inc. with the FDA for Owl Rf Insulated Cannulae.
| Device ID | K170708 |
| 510k Number | K170708 |
| Device Name: | OWL RF INSULATED CANNULAE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Diros Technology Inc. 120 Gibson Drive Markham, CA L3r 2z3 |
| Contact | Ron Baker |
| Correspondent | Ron Baker Diros Technology Inc. 120 Gibson Drive Markham, CA L3r 2z3 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-08 |
| Decision Date | 2017-06-27 |