FDA 510(k) Application Details - K160338

Device Classification Name	More FDA Info for this Device
510(K) Number	K160338
Device Name	Triton System
Applicant	GAUSS SURGICAL INC. 334 STATE STREET SUITE 201 LOS ALTOS, CA 94022 US Other 510(k) Applications for this Company
Contact	ARTIE KAUSHIK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2016
Decision Date	08/05/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review