I-125 RAPID STRAND, MODEL 7000


Device Classification Name

source, brachytherapy, radionuclide

510(k) Number K030594
Device Name I-125 RAPID STRAND, MODEL 7000
Applicant
AMERSHAM HEALTH
101 carnegie center
princeton, 
NJ 
08540 -6231

Applicant Contact subhash patel
Correspondent
AMERSHAM HEALTH
101 carnegie center
princeton, 
NJ 
08540 -6231

Correspodent Contact subhash patel
Regulation Number 892.5730
Classification Product Code
KXK  
Date Received 02/25/2003
Decision Date 04/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No