VARISOURCE BREAST TEMPLATE SYSTEM


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K023220
Device Name VARISOURCE BREAST TEMPLATE SYSTEM
Original Applicant
VARIAN MEDICAL SYSTEMS
3100 hansen way
palo alto, 
CA 
94304 -1129

Original Contact linda s nash
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 09/27/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls