The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Urf-3ap.
| Device ID | K062758 |
| 510k Number | K062758 |
| Device Name: | OWL URF-3AP |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario, CA L3r 3k8 |
| Contact | George Darmos |
| Correspondent | George Darmos DIROS TECHNOLOGY, INC. 232 HOOD ROAD Markham, Ontario, CA L3r 3k8 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2006-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825114003064 | K062758 | 000 |