FDA 510(k) Application Details - K993892

Device Classification Name Catheter, Biliary, Diagnostic

  More FDA Info for this Device
510(K) Number K993892
Device Name Catheter, Biliary, Diagnostic
Applicant C.R. BARD, INC.
129 CONCORD RD., BLDG. #3
BILLERICA, MA 01821 US
Other 510(k) Applications for this Company
Contact MARION GORDON
Other 510(k) Applications for this Contact
Regulation Number 876.5010

  More FDA Info for this Regulation Number
Classification Product Code FGE
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/16/1999
Decision Date 01/06/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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