Flexi-Seal Signal Fecal Management System

Tubes, Gastrointestinal (and Accessories)

ConvaTec Ltd.

The following data is part of a premarket notification filed by Convatec Ltd. with the FDA for Flexi-seal Signal Fecal Management System.

Pre-market Notification Details

Device IDK150350
510k NumberK150350
Device Name:Flexi-Seal Signal Fecal Management System
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant ConvaTec Ltd. Unit 20, First Ave, Deeside Industrial Park Deeside,  GB Ch5 2nu
ContactClare Williamson
CorrespondentClare Williamson
ConvaTec Ltd. Unit 20, First Ave, Deeside Industrial Park Deeside,  GB Ch5 2nu
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-11
Decision Date2015-07-21
Summary:summary

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