MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K050361
Device Name MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Applicant Contact nicholas condakes
Correspondent
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough, 
MA 
01752

Correspodent Contact nicholas condakes
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 02/14/2005
Decision Date 03/14/2005
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