FDA 510(k) Application Details - K121848

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K121848
Device Name	Catheter, Hemodialysis, Implanted
Applicant	MEDICAL COMPONENTS INC 1499 DELP DRIVE HARLEYSVILLE, PA 19438 US Other 510(k) Applications for this Company
Contact	JEAN CALLOW Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2012
Decision Date	09/21/2012
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review