FDA 510(k) Application Details - K130872

Device Classification Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene   More FDA Info for this Device
510(K) Number	K130872
Device Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant	CELXCEL PTY LTD 1801 ROCKVILLE PIKE, SUITE 300 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER SLOAN 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	03/29/2013
Decision Date	01/30/2014
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