FDA 510(k) Application Details - K931336

Device Classification Name	Dialyzer Reprocessing System   More FDA Info for this Device
510(K) Number	K931336
Device Name	Dialyzer Reprocessing System
Applicant	SERATRONICS, INC. 2637 SHADELANDS DR. WALNUT CREEK, CA 94598 US Other 510(k) Applications for this Company
Contact	SCOTT N WALKER 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	03/16/1993
Decision Date	04/18/1996
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