FDA 510(k) Application Details - K162777

Device Classification Name	More FDA Info for this Device
510(K) Number	K162777
Device Name	Squirt Fluid Delivery System
Applicant	Merit Medical Systems, Inc. 1600 W 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	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2016
Decision Date	10/31/2016
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