MODIFICATION TO: SAVI APPLICATOR KIT


Device Classification Name

system, applicator, radionuclide, remote-controlled

510(k) Number K080565
Device Name MODIFICATION TO: SAVI APPLICATOR KIT
Applicant
CIANNA MEDICAL, INC.
6 journey
suite 125
aliso viejo, 
CA 
92656

Applicant Contact gary mocnik
Correspondent
CIANNA MEDICAL, INC.
6 journey
suite 125
aliso viejo, 
CA 
92656

Correspodent Contact gary mocnik
Regulation Number 892.5700
Classification Product Code
JAQ  
Date Received 02/29/2008
Decision Date 04/04/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No