FDA 510(k) Application Details - K161805

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K161805
Device Name	Instrument, Biopsy
Applicant	SENORX, INC. 1625 WEST 3RD STREET TEMPE, AZ 85281 US Other 510(k) Applications for this Company
Contact	SARAH MCCARTNEY 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	07/01/2016
Decision Date	07/19/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review