FDA 510(k) Application Details - K232767

Device Classification Name	Membrane, Lung, (For Long-Term Respiratory Support)   More FDA Info for this Device
510(K) Number	K232767
Device Name	Membrane, Lung, (For Long-Term Respiratory Support)
Applicant	MC3 Inc. 2555 Bishop Circle West Dexter, MI 48130 US Other 510(k) Applications for this Company
Contact	Martha Rumford 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	09/11/2023
Decision Date	10/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review