The following data is part of a premarket notification filed by Diros Technology, Inc. with the FDA for Owl Radiofrequency System, Model Urf-2ap.
| Device ID | K021869 |
| 510k Number | K021869 |
| Device Name: | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | DIROS TECHNOLOGY, INC. 1837 KEMPTON RD. Charleston, SC 29412 |
| Contact | Leslie W Organ |
| Correspondent | Leslie W Organ DIROS TECHNOLOGY, INC. 1837 KEMPTON RD. Charleston, SC 29412 |
| Product Code | GXD |
| Subsequent Product Code | GXI |
| Subsequent Product Code | GZL |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-06 |
| Decision Date | 2002-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00825114000032 | K021869 | 000 |