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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 K141631
Device Name AQUARIUS EXTENSION FEEDING SET
Applicant
Degania Silicone , Ltd.
Kibbutz Degania Bet
Emek Hayarden,  IL 1513000
Applicant Contact ZOYA LEE
Correspondent
Degania Silicone , Ltd.
Kibbutz Degania Bet
Emek Hayarden,  IL 1513000
Correspondent Contact ZOYA LEE
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/18/2014
Decision Date 07/28/2014
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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