FDA 510(k) Application Details - K163597

Device Classification Name	More FDA Info for this Device
510(K) Number	K163597
Device Name	VacLok AT Vacuum Syringe
Applicant	Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Angela Brady Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2016
Decision Date	07/27/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review