FDA 510(k) Application Details - K951052

Device Classification Name	System, Applicator, Radionuclide, Manual   More FDA Info for this Device
510(K) Number	K951052
Device Name	System, Applicator, Radionuclide, Manual
Applicant	DUKE UNIVERSITY MEDICAL CENTER BOX 3010 DUKE UNIVERSITY MEDICAL CENTER DURHAM, NC 27710 US Other 510(k) Applications for this Company
Contact	KENNETH J WEEKS Other 510(k) Applications for this Contact
Regulation Number	892.5650   More FDA Info for this Regulation Number
Classification Product Code	IWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/1995
Decision Date	08/22/1996
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