FDA 510(k) Application Details - K042746

Device Classification Name	Calibrator, Dose, Radionuclide   More FDA Info for this Device
510(K) Number	K042746
Device Name	Calibrator, Dose, Radionuclide
Applicant	COMECER S.R.L. PO BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E.J. Smith 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	10/04/2004
Decision Date	11/22/2004
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	Y
Expedited Review