The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Universal Rf System Urf-3ap (ml).
| Device ID | K093185 |
| 510k Number | K093185 |
| Device Name: | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-09 |
| Decision Date | 2010-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825114000421 | K093185 | 000 |
| 00825114000025 | K093185 | 000 |
| 00825114000018 | K093185 | 000 |