FDA 510(k) Application Details - K102385

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K102385
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	NORFOLK MEDICAL PRODUCTS, INC. 7350 NORTH RIDGEWAY SKOKIE, IL 60076 US Other 510(k) Applications for this Company
Contact	MICHAEL J DALTON 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	08/23/2010
Decision Date	01/14/2011
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