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 |