FDA 510(k) Application Details - K033484

Device Classification Name	Heart Valve, More Than Minimally Manipulated Allograft   More FDA Info for this Device
510(K) Number	K033484
Device Name	Heart Valve, More Than Minimally Manipulated Allograft
Applicant	CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. KENNESAW, GA 30144 US Other 510(k) Applications for this Company
Contact	DAVID M FRONK Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2003
Decision Date	02/07/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review