FDA 510(k) Application Details - K162579

Device Classification Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene   More FDA Info for this Device
510(K) Number	K162579
Device Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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	870.3470   More FDA Info for this Regulation Number
Classification Product Code	DXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2016
Decision Date	10/14/2016
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