ONCOBIONIC BIPOLAR ELECTRODE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080287
Device Name ONCOBIONIC BIPOLAR ELECTRODE
Applicant
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Applicant Contact teri juckett
Correspondent
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Correspodent Contact teri juckett
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 02/04/2008
Decision Date 07/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No