FDA 510(k) Application Details - K190539

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K190539
Device Name	Stopcock, I.V. Set
Applicant	MonuMedical, LLC 3017 Douglas Blvd, Suite 300 Roseville, CA 95661 US Other 510(k) Applications for this Company
Contact	John Knapik Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2019
Decision Date	10/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review