FDA 510(k) Application Details - K152624

Device Classification Name	More FDA Info for this Device
510(K) Number	K152624
Device Name	XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
Applicant	REVMEDX, INC. 25999 SW CANYON CREEK ROAD, SUITE C WILSONVILLE, OR 97070 US Other 510(k) Applications for this Company
Contact	AMY K. POINTER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2015
Decision Date	12/07/2015
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