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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
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