FDA 510(k) Application Details - K955002

Device Classification Name	Catheter, Hemodialysis, Non-Implanted   More FDA Info for this Device
510(K) Number	K955002
Device Name	Catheter, Hemodialysis, Non-Implanted
Applicant	QUINTON, INC. 3303 MONTE VILLA PKWY. BOTHELL, WA 98021-8906 US Other 510(k) Applications for this Company
Contact	LYNN LAYMAN-SPILLAR 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	11/01/1995
Decision Date	09/13/1996
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