FDA 510(k) Application Details - K000475

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K000475
Device Name	Source, Brachytherapy, Radionuclide
Applicant	DRAXIMAGE, INC. 16751 TRANS CANADA HIGHWAY KIRKLAND, QC H9H 4J4 CA Other 510(k) Applications for this Company
Contact	R.J. FLANAGAN 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	02/15/2000
Decision Date	08/22/2000
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