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 |
|