FDA 510(k) Application Details - K173358

Device Classification Name	More FDA Info for this Device
510(K) Number	K173358
Device Name	ARTAS System
Applicant	Restoration Robotics, Inc. 128 Baytech Drive San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Raymond Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ONA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2017
Decision Date	03/16/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review