G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080844
Device Name G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
Applicant
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Applicant Contact lorraine calzetta
Correspondent
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Correspodent Contact lorraine calzetta
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 03/26/2008
Decision Date 08/13/2009
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