FDA 510(k) Application Details - DEN150038

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150038
Device Name	CleanCisionTM Wound Retraction and Protection System
Applicant	Prescient Surgical 1585 Industrial Road San Carlos, CA 94070 US Other 510(k) Applications for this Company
Contact	Lisa Ruehlow Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2015
Decision Date	12/16/2016
Decision	DENG -
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review