The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Rulo Radiofrequency Lesion Probe.
| Device ID | K190256 |
| 510k Number | K190256 |
| Device Name: | Rulo Radiofrequency Lesion Probe |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | Epimed International, Inc. 13958 Diplomat Drive Farmers Branch, TX 75234 |
| Contact | Preston H. Frasier |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo, MN 55313 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-02-07 |
| Decision Date | 2019-03-08 |