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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 K102536
Device Name VITALA CONTINENCE CONTROL DEVICE
Applicant
Convatec, Inc.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact CHARLES RYAN
Correspondent
Convatec, Inc.
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact CHARLES RYAN
Regulation Number876.5900
Classification Product Code
EZQ  
Date Received09/03/2010
Decision Date 12/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00902252
NCT01138709
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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