FDA 510(k) Application Details - K033570

Device Classification Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted   More FDA Info for this Device
510(K) Number	K033570
Device Name	Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Applicant	MEDCOMP 1499 DELP DR. 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	NIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2003
Decision Date	09/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review