Evolution Esophageal Stent System – Partially Covered

Prosthesis, Esophageal

Cook Ireland Ltd.

The following data is part of a premarket notification filed by Cook Ireland Ltd. with the FDA for Evolution Esophageal Stent System – Partially Covered.

Pre-market Notification Details

Device IDK162717
510k NumberK162717
Device Name:Evolution Esophageal Stent System – Partially Covered
ClassificationProsthesis, Esophageal
Applicant Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick,  IE
ContactJane Kennedy
CorrespondentJane Kennedy
Cook Ireland Ltd. O'Halloran Road, National Technology Park Limerick,  IE
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-29
Decision Date2016-12-21
Summary:summary

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