FDA 510(k) Application Details - DEN150028

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150028
Device Name	PneumoLiner
Applicant	ADVANCED SURGICAL CONCEPTS LTD. UNIT 4 SUNNYBANK CENTER, UPPER DARGLE ROAD BRAY IRL IE Other 510(k) Applications for this Company
Contact	EDWARD HYLAND Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2015
Decision Date	04/07/2016
Decision	DENG -
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review