FDA 510(k) Application Details - K052416

Device Classification Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene   More FDA Info for this Device
510(K) Number	K052416
Device Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant	HANCOCK/JAFFE LABORATORIES 2807 MCGAW AVE. IRVINE, CA 92614 US Other 510(k) Applications for this Company
Contact	SUE MONTOYA 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	09/02/2005
Decision Date	10/25/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review