FDA 510(k) Application Details - K160400

Device Classification Name	More FDA Info for this Device
510(K) Number	K160400
Device Name	Miromatrix Biological Mesh
Applicant	MIROMATRIX MEDICAL INC. 10399 WEST 70TH ST Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	JEFF ROSS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2016
Decision Date	06/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review