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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gastrointestinal tubes with enteral specific connectors
510(k) Number K141753
Device Name AQUARIUS NASAL FEEDING TUBE
Applicant
DEGANIA SILICONE, LTD.
DEGANIA BET
EMEK HAYARDEN,  IL 15130
Applicant Contact ZOYA LEE
Correspondent
DEGANIA SILICONE, LTD.
DEGANIA BET
EMEK HAYARDEN,  IL 15130
Correspondent Contact ZOYA LEE
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
FPD  
Date Received06/30/2014
Decision Date 10/16/2014
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
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