Allergan Botox Needle Electrode

Electrode, Needle, Diagnostic Electromyograph

Natus Manufacturing Limited

The following data is part of a premarket notification filed by Natus Manufacturing Limited with the FDA for Allergan Botox Needle Electrode.

Pre-market Notification Details

Device IDK173815
510k NumberK173815
Device Name:Allergan Botox Needle Electrode
ClassificationElectrode, Needle, Diagnostic Electromyograph
Applicant Natus Manufacturing Limited IDA Business Park Gort,  IE H91 Pd92
ContactMaria Connolly
CorrespondentMartha Kennedy
Natus Manufacturing Limited IDA Business Park Gort,  IE H91 Pd92
Product CodeIKT  
CFR Regulation Number890.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-15
Decision Date2018-06-29
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.