CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K080791
Device Name CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45
Applicant
SENORX, INC.
11 columbia
aliso viejo, 
CA 
92656

Applicant Contact eben gordon
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 03/20/2008
Decision Date 04/30/2008
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