FDA 510(k) Application Details - K181038

Device Classification Name	More FDA Info for this Device
510(K) Number	K181038
Device Name	CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
Applicant	CorMatrix Cardiovascular, Inc. 1100 Old Ellis Rd. Roswell, GA 30076 US Other 510(k) Applications for this Company
Contact	Wendy Perreault 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	04/19/2018
Decision Date	10/10/2018
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