FDA 510(k) Application Details - K143074

Device Classification Name	System&Accessories,Isolated Heart,Transport&Preservation   More FDA Info for this Device
510(K) Number	K143074
Device Name	System&Accessories,Isolated Heart,Transport&Preservation
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	MSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2014
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