The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Rf Cannulate.
| Device ID | K090955 |
| 510k Number | K090955 |
| Device Name: | SMITH & NEPHEW RF CANNULATE |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Mason W Robbins |
| Correspondent | Mason W Robbins SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-06 |
| Decision Date | 2009-07-16 |
| Summary: | summary |