FDA 510(k) Application Details - K172132

Device Classification Name	More FDA Info for this Device
510(K) Number	K172132
Device Name	CleanCision Wound Retraction and Protection System
Applicant	Prescient Surgical, Inc. 1585 Industrial Rd. San Carlos, CA 94070 US Other 510(k) Applications for this Company
Contact	Lisa Claude 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	07/14/2017
Decision Date	10/25/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review