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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 K162906
Device Name Flexi-Seal PROTECT Fecal Management System
Applicant
ConvaTec
GDC, First Avenue, Deeside Industrial Park
Deeside,  GB ch5 2nu
Applicant Contact Karen Howes
Correspondent
ConvaTec
GDC, First Avenue, Deeside Industrial Park
Deeside,  GB ch5 2nu
Correspondent Contact Karen Howes
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/17/2016
Decision Date 03/07/2017
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
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