FDA 510(k) Application Details - K022221

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K022221
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	DELTEC, INC. 1265 GREY FOX RD. ST. PAUL, MN 55112 US Other 510(k) Applications for this Company
Contact	LISA STONE 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	07/09/2002
Decision Date	01/30/2003
Decision	SESK - SUBST EQUIV - KIT
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