FDA 510(k) Application Details - K002833

Device Classification Name	Calibrator, Dose, Radionuclide   More FDA Info for this Device
510(K) Number	K002833
Device Name	Calibrator, Dose, Radionuclide
Applicant	STANDARD IMAGING, INC. 7601 MURPHY DR. MIDDLETON, WI 53562-2766 US Other 510(k) Applications for this Company
Contact	RAYMOND RIDDLE Other 510(k) Applications for this Contact
Regulation Number	892.1360   More FDA Info for this Regulation Number
Classification Product Code	KPT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2000
Decision Date	09/28/2000
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