FDA 510(k) Application Details - K173601

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K173601
Device Name	Syringe, Piston
Applicant	Merit Medical Systems, Inc. 1600 W Merit Parkway South Jordan, UT 84045 US Other 510(k) Applications for this Company
Contact	Cory Marsh Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2017
Decision Date	01/31/2018
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