FDA 510(k) Application Details - K120281

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K120281
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	MEDICAL COMPONENTS INC 1499 DELP DRIVE HARLEYSVILLE, PA 19438 US Other 510(k) Applications for this Company
Contact	ROSANNA SEVERINI 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	01/31/2012
Decision Date	09/17/2012
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