FDA 510(k) Application Details - K974570

Device Classification Name	Catheter, Peritoneal Dialysis, Single Use   More FDA Info for this Device
510(K) Number	K974570
Device Name	Catheter, Peritoneal Dialysis, Single Use
Applicant	MEDIGROUP, INC. 615 ENTERPRISE ST. AURORA, IL 60504-8138 US Other 510(k) Applications for this Company
Contact	JOHN NAVIS 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	12/08/1997
Decision Date	02/27/1998
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