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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 K133465
Device Name CONSURE STOOL MANAGEMENT SYSTEM
Applicant
Consure Medical Pvt , Ltd.
11440 W. Bernardo Ct.
Suite 300
San Diego,  CA  92127
Applicant Contact ALAN DONALD
Correspondent
Consure Medical Pvt , Ltd.
11440 W. Bernardo Ct.
Suite 300
San Diego,  CA  92127
Correspondent Contact ALAN DONALD
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/12/2013
Decision Date 06/26/2014
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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