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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 K212444
Device Name Qora Stool Management Kit
Applicant
CM Technologies, Inc.
2165 San Diego Avenue
San Diego,  CA  92110
Applicant Contact Nishith Chasmawala
Correspondent
Matrix Medical Consulting, Inc.
8880 Rio San Diego Drive, Suite 800
San Diego,  CA  92108
Correspondent Contact Alan Donald
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/05/2021
Decision Date 11/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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