FDA 510(k) Application Details - K200661

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K200661
Device Name	Set, Administration, Intravascular
Applicant	Magnolia Medical Technologies Inc. 200 West Mercer Street, Suite 500 Seattle, WA 98119 US Other 510(k) Applications for this Company
Contact	Gregory J. Bullington Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2020
Decision Date	10/08/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review