ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT


Device Classification Name

low energy direct current thermal ablation system

510(k) Number K080202
Device Name ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
Applicant
ONCOBIONICS, INC.
30211 avenida de las banderas
suite 200
rancho santa margarita, 
CA 
92679

Applicant Contact paul mikus
Correspondent
ONCOBIONICS, INC.
30211 avenida de las banderas
suite 200
rancho santa margarita, 
CA 
92679

Correspodent Contact paul mikus
Regulation Number 878.4400
Classification Product Code
OAB  
Date Received 01/28/2008
Decision Date 05/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls