K-number	K162906
Device name	Flexi-Seal PROTECT Fecal Management System
Applicant	Convatec
Product code	KNT
Device class	Class II
Decision date	Mar 7, 2017
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Flexi-Seal PROTECT Fecal Management System

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