Natrelle 133S Tissue Expander

Expander, Skin, Inflatable

Allergan

The following data is part of a premarket notification filed by Allergan with the FDA for Natrelle 133s Tissue Expander.

Pre-market Notification Details

Device IDK182054
510k NumberK182054
Device Name:Natrelle 133S Tissue Expander
ClassificationExpander, Skin, Inflatable
Applicant Allergan 2525 Dupont Drive Irvine,  CA  92612
ContactMelissa Pathmajeyan
CorrespondentMelissa Pathmajeyan
Allergan 2525 Dupont Drive Irvine,  CA  92612
Product CodeLCJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-31
Decision Date2018-08-29
Summary:summary

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