FDA 510(k) Application Details - K170951

Device Classification Name	More FDA Info for this Device
510(K) Number	K170951
Device Name	CardioCel 3D
Applicant	Admedus Regen Pty Ltd 26 Harris Road Malaga 6090 AU Other 510(k) Applications for this Company
Contact	Mary E. Donlin 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	03/31/2017
Decision Date	04/28/2017
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