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FDA 510(k) Application Details - K133734
Device Classification Name
Endoscopic Irrigation/Suction System
More FDA Info for this Device
510(K) Number
K133734
Device Name
Endoscopic Irrigation/Suction System
Applicant
ENDOCHOICE, INC.
11810 WILLS RD.
ALPHARETTA, GA 30009 US
Other 510(k) Applications for this Company
Contact
JANNA BABSON
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
OCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2013
Decision Date
03/19/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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