CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K081079
Device Name CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
Applicant
SENORX, INC.
11 columbia
aliso viejo, 
CA 
92656

Applicant Contact eben gordon
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 04/16/2008
Decision Date 05/02/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No