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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 K083785
Device Name VITALA CONTINENCE CONTROL DEVICE
Applicant
Convatec
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact MARILYN KONICKY
Correspondent
Convatec
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact MARILYN KONICKY
Regulation Number876.5900
Classification Product Code
EZQ  
Date Received12/19/2008
Decision Date 04/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00809406
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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