The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Neurotherm Rf Cannula.
| Device ID | K994344 |
| 510k Number | K994344 |
| Device Name: | NEUROTHERM RF CANNULA |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | ROCKET MEDICAL PLC FACTORIES 3 & 4, WEAR INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne37 1ne |
| Contact | Les Todd |
| Correspondent | Les Todd ROCKET MEDICAL PLC FACTORIES 3 & 4, WEAR INDUSTRIAL ESTATE Washington, Tyne & Wear, GB Ne37 1ne |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-03-21 |
| Summary: | summary |