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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pouch, Colostomy
510(k) Number K111365
Device Name VITALA CONTINENCE CONTROL DEVICE
Applicant
Convatec, Inc.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact MARK R JAKUBOWSKI
Correspondent
Convatec, Inc.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact MARK R JAKUBOWSKI
Regulation Number876.5900
Classification Product Code
EZQ  
Date Received05/16/2011
Decision Date 08/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT01207479
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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