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FDA 510(k) Application Details - DEN180062
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN180062
Device Name
EchoTip Insight Portosystemic Pressure Gradient Measuring System
Applicant
Cook Ireland Ltd.
O'Halloran Road, National Technology Park
Limerick IE
Other 510(k) Applications for this Company
Contact
Jane Kennedy
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QIJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2018
Decision Date
11/20/2019
Decision
DENG -
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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