GUARDIAN 150 ELECTRODE

Electrode, Cutaneous

SELECTIVE MED COMPONENTS, INC.

The following data is part of a premarket notification filed by Selective Med Components, Inc. with the FDA for Guardian 150 Electrode.

Pre-market Notification Details

Device IDK083756
510k NumberK083756
Device Name:GUARDIAN 150 ELECTRODE
ClassificationElectrode, Cutaneous
Applicant SELECTIVE MED COMPONENTS, INC. 845 ARONSON LAKE COURT Roswell,  GA  30075
ContactJay Mansour
CorrespondentJay Mansour
SELECTIVE MED COMPONENTS, INC. 845 ARONSON LAKE COURT Roswell,  GA  30075
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-17
Decision Date2009-06-26
Summary:summary

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