ECHOSEED/IODINE-125 SEEDS, MODEL 6733


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K010821
Device Name ECHOSEED/IODINE-125 SEEDS, MODEL 6733
Original Applicant
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING
3350 ridge ave.
arlington heights, 
IL 
60004

Original Contact subhash patel
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 03/19/2001
Decision Date 04/11/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No