The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Diros Owl Sterile Single Use Tridenttm R.f. Insulated Cannulae,models Dtr And Dtrh.
| Device ID | K150371 |
| 510k Number | K150371 |
| Device Name: | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR And DTRH |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | DIROS TECHNOLOGY, INC. 120 GIBSON DRIVE Markham, CA L3r 2z3 |
| Contact | George Darmos |
| Correspondent | George Darmos DIROS TECHNOLOGY, INC. 120 GIBSON DRIVE Markham, CA L3r 2z3 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-13 |
| Decision Date | 2015-07-30 |
| Summary: | summary |