FDA 510(k) Application Details - K191734

Device Classification Name	More FDA Info for this Device
510(K) Number	K191734
Device Name	MatriStem UBM Pericardial Patch
Applicant	Acell, Inc. 6640 Eli Whitney Drive Suite 200 Columbia, MD 21046 US Other 510(k) Applications for this Company
Contact	Michelle Huettner Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2019
Decision Date	11/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review