FDA 510(k) Application Details - K192898

Device Classification Name	More FDA Info for this Device
510(K) Number	K192898
Device Name	PneumoLiner
Applicant	Advanced Surgical Concepts Unit 4, Sunnybank Center, Upper Dargle Road Bray A98 E339 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	10/11/2019
Decision Date	02/25/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review