FDA 510(k) Application Details - K081066

Device Classification Name	Seed, Isotope, Gold, Titanium, Platinum   More FDA Info for this Device
510(K) Number	K081066
Device Name	Seed, Isotope, Gold, Titanium, Platinum
Applicant	MEDI-PHYSICS, INC., DBA GE HEALTHCARE 101 CARNEGIE CENTRE PRINCETON, NJ 08540-6231 US Other 510(k) Applications for this Company
Contact	DAVID RISLEY Other 510(k) Applications for this Contact
Regulation Number	892.5730   More FDA Info for this Regulation Number
Classification Product Code	IWG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2008
Decision Date	05/05/2008
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