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FDA 510(k) Application Details - K152140
Device Classification Name
Endoscopic Irrigation/Suction System
More FDA Info for this Device
510(K) Number
K152140
Device Name
Endoscopic Irrigation/Suction System
Applicant
C2 THERAPEUTICS, INC.
303 CONVENTION WAY, SUITE 1
REDWOOD CITY, CA 94063 US
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Contact
THERESA BRANDNER-ALLEN
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
OCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2015
Decision Date
10/13/2015
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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