FDA 510(k) Application Details - K191935

Device Classification Name	Membrane, Lung, (For Long-Term Respiratory Support)   More FDA Info for this Device
510(K) Number	K191935
Device Name	Membrane, Lung, (For Long-Term Respiratory Support)
Applicant	MC3 Incorporated 2555 Bishop Circle W Dexter, MI 48130 US Other 510(k) Applications for this Company
Contact	Adam Viitala Other 510(k) Applications for this Contact
Regulation Number	868.5610   More FDA Info for this Regulation Number
Classification Product Code	BYS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2019
Decision Date	04/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review