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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K190512
Device Name SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
Applicant
Intelligent Endoscopy
4740 Commercial Park Ct., Suite 1
Clemmons,  NC  27012
Applicant Contact Melissa Clark
Correspondent
Intelligent Endoscopy
4740 Commercial Park Ct., Suite 1
Clemmons,  NC  27012
Correspondent Contact Melissa Clark
Regulation Number876.4300
Classification Product Code
FDI  
Date Received03/01/2019
Decision Date 11/22/2019
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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