FDA 510(k) Application Details - K002429

Device Classification Name Source, Brachytherapy, Radionuclide

  More FDA Info for this Device
510(K) Number K002429
Device Name Source, Brachytherapy, Radionuclide
Applicant NUCLETRON CORP.
7080 COLUMBIA GATEWAY DR.
COLUMBIA, MD 21046 US
Other 510(k) Applications for this Company
Contact ROBERT APPLEBAUM
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 08/08/2000
Decision Date 02/02/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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