FDA 510(k) Application Details - K161315

Device Classification Name	Clamp, Vascular   More FDA Info for this Device
510(K) Number	K161315
Device Name	Clamp, Vascular
Applicant	AROS Surgical Instruments Corporation 2111 Descanso Newport Beach, CA 92660 US Other 510(k) Applications for this Company
Contact	Fred Phleps Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	DXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2016
Decision Date	08/18/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review