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FDA 510(k) Application Details - K143054
Device Classification Name
System, Perfusion, Kidney
More FDA Info for this Device
510(K) Number
K143054
Device Name
System, Perfusion, Kidney
Applicant
PARAGONIX TECHNOLOGIES, INC.
639 GRANITE STREET
BRAINTREE, MA 02184 US
Other 510(k) Applications for this Company
Contact
Lisa Anderson
Other 510(k) Applications for this Contact
Regulation Number
876.5880
More FDA Info for this Regulation Number
Classification Product Code
KDN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/23/2014
Decision Date
11/25/2014
Decision
SESK - SUBST EQUIV - KIT
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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