FDA 510(k) Application Details - K033936

Device Classification Name Dilator, Esophageal

  More FDA Info for this Device
510(K) Number K033936
Device Name Dilator, Esophageal
Applicant C.R. BARD, INC.
129 CONCORD ROAD
BUILDING 3
BILLERICA, MA 01821 US
Other 510(k) Applications for this Company
Contact MICHAEL A PATZ
Other 510(k) Applications for this Contact
Regulation Number 876.5365

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

  More FDA Info for this Product Code
Date Received 12/19/2003
Decision Date 01/14/2004
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