The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Cannulae.
| Device ID | K141586 |
| 510k Number | K141586 |
| Device Name: | OWL CANNULAE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | DIROS TECHNOLOGY, INC. 120 GIBSON DRIVE Markham,on, CA L3r 2z3 |
| Contact | George Darmos |
| Correspondent | George Darmos DIROS TECHNOLOGY, INC. 120 GIBSON DRIVE Markham,on, 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 | 2014-06-13 |
| Decision Date | 2014-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825114006652 | K141586 | 000 |
| 00825114002630 | K141586 | 000 |
| 00825114002654 | K141586 | 000 |
| 00825114002661 | K141586 | 000 |
| 00825114002685 | K141586 | 000 |
| 00825114002708 | K141586 | 000 |
| 00825114002722 | K141586 | 000 |
| 00825114006430 | K141586 | 000 |
| 00825114006454 | K141586 | 000 |
| 825114006478 | K141586 | 000 |
| 00825114006492 | K141586 | 000 |
| 00825114006515 | K141586 | 000 |
| 00825114006539 | K141586 | 000 |
| 00825114006553 | K141586 | 000 |
| 00825114006577 | K141586 | 000 |
| 00825114006591 | K141586 | 000 |
| 00825114006614 | K141586 | 000 |
| 00825114006638 | K141586 | 000 |
| 00825114006478 | K141586 | 000 |