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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 K153506
Device Name Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
Applicant
Consure Medical Pvt , Ltd.
5l, Third Floor, Shahpur Jat
New Delhi,  IN 110049
Applicant Contact Nishith Chasmawala
Correspondent
Matrix Medical Consulting, Inc.
8880 Rio San Diego Dr. Suite 800
San Diego,  CA  92108
Correspondent Contact Alan Donald
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/07/2015
Decision Date 05/06/2016
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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