FDA 510(k) Application Details - K003615

Device Classification Name	System, Dialysate Delivery, Single Patient   More FDA Info for this Device
510(K) Number	K003615
Device Name	System, Dialysate Delivery, Single Patient
Applicant	ENVIRONMENTAL TEST SYSTEMS, INC. P.O. BOX 4659 ELKHART, IN 46514 US Other 510(k) Applications for this Company
Contact	BRUCE G PIEKARSKI Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2000
Decision Date	02/01/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review