FDA 510(k) Application Details - K011576

Device Classification Name	Kit, Repair, Catheter, Hemodialysis   More FDA Info for this Device
510(K) Number	K011576
Device Name	Kit, Repair, Catheter, Hemodialysis
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	NFK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2001
Decision Date	06/21/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review