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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K190114
Device Name Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
Applicant
Convatec Limited
Gdc, First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Applicant Contact Karen Howes
Correspondent
Convatec Limited
Gdc, First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Correspondent Contact Karen Howes
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
PIF  
Date Received01/24/2019
Decision Date 04/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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