FDA 510(k) Application Details - K960787

Device Classification Name	System, Irrigation, Urological   More FDA Info for this Device
510(K) Number	K960787
Device Name	System, Irrigation, Urological
Applicant	BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. ROUND LAKE, IL 60073 US Other 510(k) Applications for this Company
Contact	MARY-ELLEN SAYDER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LJH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/1996
Decision Date	05/14/1996
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