DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,

Electrode, Needle

TECHNOMED EUROPE

The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable And Reusable Concentric Needle Electrodes,disposable And Reusable Subdermal Needle Electrodes,.

Pre-market Notification Details

Device IDK130136
510k NumberK130136
Device Name:DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
ClassificationElectrode, Needle
Applicant TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
ContactPierre Vreuls
CorrespondentPierre Vreuls
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 Received2013-01-18
Decision Date2013-07-19
Summary:summary

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