DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE

Electrode, Needle

TECHNOMED EUROPE

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.

Pre-market Notification Details

Device IDK050325
510k NumberK050325
Device Name:DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
ClassificationElectrode, Needle
Applicant TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
ContactRene Roncken
CorrespondentRene Roncken
TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
Product CodeGXZ  
CFR Regulation Number882.1350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-09
Decision Date2005-05-05
Summary:summary

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