FDA 510(k) Application Details - K170334

Device Classification Name	More FDA Info for this Device
510(K) Number	K170334
Device Name	XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 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	02/02/2017
Decision Date	05/01/2017
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