The following data is part of a premarket notification filed by Technomed Europe with the FDA for Smk, Cx, Cxe, Rcn.
| Device ID | K042375 |
| 510k Number | K042375 |
| Device Name: | SMK, CX, CXE, RCN |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Contact | Rene Roncken |
| Correspondent | Rene Roncken TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Product Code | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-01 |
| Decision Date | 2004-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415067021912 | K042375 | 000 |
| 15415067021806 | K042375 | 000 |
| 15415067021813 | K042375 | 000 |
| 15415067021820 | K042375 | 000 |
| 15415067021837 | K042375 | 000 |
| 15415067021844 | K042375 | 000 |
| 15415067021851 | K042375 | 000 |
| 15415067021868 | K042375 | 000 |
| 15415067021875 | K042375 | 000 |
| 15415067021882 | K042375 | 000 |
| 15415067021899 | K042375 | 000 |
| 15415067021905 | K042375 | 000 |
| 15415067021790 | K042375 | 000 |