FDA 510(k) Application Details - K183635

Device Classification Name	More FDA Info for this Device
510(K) Number	K183635
Device Name	PhotoFix Decellularized Bovine Pericardium
Applicant	CryoLife, Inc. 1655 Roberts Blvd. NW Kennesaw, GA 30144 US Other 510(k) Applications for this Company
Contact	Heather Emerick 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	12/26/2018
Decision Date	02/14/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review