FDA 510(k) Application Details - K153337

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K153337
Device Name	Instrument, Biopsy
Applicant	MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PARKWAY SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	Ileana Davis Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2015
Decision Date	03/25/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review