Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K123326
Device Classification Name
System&Accessories,Isolated Heart,Transport&Preservation
More FDA Info for this Device
510(K) Number
K123326
Device Name
System&Accessories,Isolated Heart,Transport&Preservation
Applicant
PARAGONIX TECHNOLOGIES, INC.
755 WESTMINISTER STREET UNIT 120
PROVIDENCE, MA 02903 US
Other 510(k) Applications for this Company
Contact
LEO BASTA
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
10/26/2012
Decision Date
02/06/2013
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact