The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe.
| Device ID | K050325 |
| 510k Number | K050325 |
| Device Name: | DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE |
| Classification | Electrode, Needle |
| 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 | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-05-05 |
| Summary: | summary |