FDA 510(k) Application Details - DEN130015

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130015
Device Name	PIXEL 3 SYSTEM
Applicant	GAUSS SURGICAL, INC. 334 STATE ST., SUITE 201 LOS ALTOS, CA 94022 US Other 510(k) Applications for this Company
Contact	PEGGY MCLAUGHLIN 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	02/04/2013
Decision Date	05/09/2014
Decision	DENG -
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review