FDA 510(k) Application Details - K965178

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K965178
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	VAS-CATH, INC. 2380 TEDLO ST. MISSISSAUGA ONTARIO, L5A 3V3 CA Other 510(k) Applications for this Company
Contact	DOLORES MCGIRR 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	12/24/1996
Decision Date	08/19/1997
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