FDA 510(k) Application Details - K041576

Device Classification Name Source, Brachytherapy, Radionuclide

  More FDA Info for this Device
510(K) Number K041576
Device Name Source, Brachytherapy, Radionuclide
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014-2655 US
Other 510(k) Applications for this Company
Contact JOHN C KNORPP
Other 510(k) Applications for this Contact
Regulation Number 892.5730

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

  More FDA Info for this Product Code
Date Received 06/11/2004
Decision Date 07/02/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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