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FDA 510(k) Application Details - K142327
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K142327
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
ART Healthcare Ltd.
7 Hashlosha St.
Even-Yehuda 4053423 IL
Other 510(k) Applications for this Company
Contact
Liron Elia
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/20/2014
Decision Date
06/08/2015
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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