FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM

Tubes, Gastrointestinal (and Accessories)

CONVATEC INC

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

Pre-market Notification Details

Device IDK112342
510k NumberK112342
Device Name:FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant CONVATEC INC 200 HEADQUARTERS PARK DRIVE Skillman,  NJ  08558
ContactKatrina Fiedler
CorrespondentKatrina Fiedler
CONVATEC INC 200 HEADQUARTERS PARK DRIVE Skillman,  NJ  08558
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-15
Decision Date2012-04-26
Summary:summary

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