FDA 510(k) Application Details - K150341

Device Classification Name	More FDA Info for this Device
510(K) Number	K150341
Device Name	Miromatrix Biological Mesh RS
Applicant	MIROMATRIX MEDICAL INC. 18683 Bearpath Trail Eden Prairie, MN 55347 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	02/11/2015
Decision Date	05/12/2015
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