The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Rf Denervation Probes & Rf Cannulae.
| Device ID | K034012 |
| 510k Number | K034012 |
| Device Name: | SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Karen Provencher |
| Correspondent | Karen Provencher SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-03-16 |
| Summary: | summary |