FDA 510(k) Application Details - K081425

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K081425
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	COOK VASCULAR, INC. 1186 MONTGOMERY LANE VANDERGRIFT, PA 15690 US Other 510(k) Applications for this Company
Contact	JIM FERGUSON Other 510(k) Applications for this Contact
Regulation Number	880.5965   More FDA Info for this Regulation Number
Classification Product Code	LJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2008
Decision Date	09/30/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review