FDA 510(k) Application Details - K010399

Device Classification Name	Catheter, Hemodialysis, Implanted   More FDA Info for this Device
510(K) Number	K010399
Device Name	Catheter, Hemodialysis, Implanted
Applicant	DIATEK, INC. 101 N. CHESTNUT ST. #300 WINSTON-SALEM, NC 27101 US Other 510(k) Applications for this Company
Contact	TODD CASSIDY 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	02/09/2001
Decision Date	08/14/2001
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