FDA 510(k) Application Details - K010821

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K010821
Device Name	Source, Brachytherapy, Radionuclide
Applicant	MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING 3350 RIDGE AVE. ARLINGTON HEIGHTS, IL 60004 US Other 510(k) Applications for this Company
Contact	SUBHASH PATEL 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	03/19/2001
Decision Date	04/11/2001
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