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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 K142548
Device Name MIDSLEEVE
Applicant
Medical Innovation Development
9, Chemin Du Jubin
Dardilly,  FR
Applicant Contact Melanie Fouilland
Correspondent
Medical Innovation Development
9, Chemin Du Jubin
Dardilly,  FR
Correspondent Contact Melanie Fouilland
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/10/2014
Decision Date 06/23/2015
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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