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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact