FDA 510(k) Application Details - K081288

Device Classification Name	More FDA Info for this Device
510(K) Number	K081288
Device Name	ASPIRA PERITONEAL DRAINAGE SYSTEM
Applicant	C.R. BARD, INC. 605 NORTH 5600 WEST SALT LAKE CITY, UT 84116 US Other 510(k) Applications for this Company
Contact	HENRY BOLAND Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2008
Decision Date	07/18/2008
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