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FDA 510(k) Applications Submitted by Karen Howes
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190114
01/24/2019
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
ConvaTec Limited
K162906
10/17/2016
Flexi-Seal PROTECT Fecal Management System
ConvaTec
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