FDA 510(k) Application Details - K994016

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K994016
Device Name	Source, Brachytherapy, Radionuclide
Applicant	SYNCOR PHARMACEUTICALS, INC. 1313 WASHINGTON AVE. GOLDEN, CO 80401 US Other 510(k) Applications for this Company
Contact	GARY GILMORE 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	11/26/1999
Decision Date	07/14/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review