FDA 510(k) Application Details - K061815

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K061815
Device Name	Filter, Intravascular, Cardiovascular
Applicant	WILLIAM COOK EUROPE APS 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON, IN 47402-0489 US Other 510(k) Applications for this Company
Contact	THALIA BRINE Other 510(k) Applications for this Contact
Regulation Number	870.3375   More FDA Info for this Regulation Number
Classification Product Code	DTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2006
Decision Date	04/20/2007
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