FDA 510(k) Application Details - K130576

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K130576
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	B. BRAUN INTERVENTIONAL SYSTEMS INC. 3100 W Lake St Ste 420 Minneapolis, MN 55416 US Other 510(k) Applications for this Company
Contact	AMBER KINGSTON 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	03/05/2013
Decision Date	04/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review