FDA 510(k) Application Details - K141753

Device Classification Name

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510(K) Number K141753
Device Name AQUARIUS NASAL FEEDING TUBE
Applicant DEGANIA SILICONE, LTD.
DEGANIA BET
EMEK HAYARDEN 15130 IL
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Contact ZOYA LEE
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Regulation Number

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Classification Product Code PIF
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Date Received 06/30/2014
Decision Date 10/16/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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