The following data is part of a premarket notification filed by Leslie W. Organ with the FDA for Owl Radiofrequency System, Model Urf-2a, And Associate Radiofrequency Lesion Probes.
| Device ID | K010202 |
| 510k Number | K010202 |
| Device Name: | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | LESLIE W. ORGAN 1837 KEMPTON RD. Charleston, SC 29412 |
| Contact | Leslie W Organ |
| Correspondent | Leslie W Organ LESLIE W. ORGAN 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-10-31 |