FDA 510(k) Application Details - K103109

Device Classification Name Tubes, Gastrointestinal (And Accessories)

  More FDA Info for this Device
510(K) Number K103109
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant C.R. BARD INC
605 NORTH 5600 WEST
SALT LAKE CITY, UT 84116 US
Other 510(k) Applications for this Company
Contact DENNIS SALZMANN
Other 510(k) Applications for this Contact
Regulation Number 876.5980

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

  More FDA Info for this Product Code
Date Received 10/21/2010
Decision Date 12/22/2010
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