FDA 510(k) Application Details - K161067

Device Classification Name	More FDA Info for this Device
510(K) Number	K161067
Device Name	Mirragen Advanced Wound Matrix, 4x4ö, Mirragen Advanced Wound Matrix, 2x2ö, Mirragen Advanced Wound Matrix, 1x6ö
Applicant	ENGINEERED TISSUE SOLUTIONS, LLC 4030 HYPOINT NORTH Rolla, MO 65401 US Other 510(k) Applications for this Company
Contact	Mark Borden Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2016
Decision Date	09/15/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review