FDA 510(k) Application Details - K964514

Device Classification Name	Catheter, Peritoneal Dialysis, Single Use   More FDA Info for this Device
510(K) Number	K964514
Device Name	Catheter, Peritoneal Dialysis, Single Use
Applicant	CORPAK, INC. 100 CHADDICK DR. WHEELING, IL 60090 US Other 510(k) Applications for this Company
Contact	ROBERT E BOOTH Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	FKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/1996
Decision Date	06/26/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review