FDA 510(k) Application Details - K974798

Device Classification Name	Dialyzer Reprocessing System   More FDA Info for this Device
510(K) Number	K974798
Device Name	Dialyzer Reprocessing System
Applicant	ENVIRONMENTAL TEST SYSTEMS, INC. 23575 COUNTY RD., #106 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	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1997
Decision Date	03/20/1998
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