FDA 510(k) Application Details - K983511

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K983511
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	MEDICAL COMPONENTS, INC. 1499 DELP DR. HARLEYSVILLE, PA 19438 US Other 510(k) Applications for this Company
Contact	JEANNE M CUSH Other 510(k) Applications for this Contact
Regulation Number	876.5540   More FDA Info for this Regulation Number
Classification Product Code	MPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/1998
Decision Date	06/08/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review