FDA 510(k) Application Details - K140169

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K140169
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	THOMAS J KARDOS 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	01/23/2014
Decision Date	05/21/2014
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