ConvaTec Canada Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30128817403012881740ConvaTec Canada Ltd.1N2026-01-011425 TransCanada Highway Suite 100 Dorval Quebec CA H9P 2V3

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1997261623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1997262005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
1997261945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1997261995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
1997261508716359K032734CONVATEC FECAL MANAGEMENT SYSTEMKNT2004-04-08
1997261466573805

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNT52019-04-30