ION MEDICAL BIPOLAR COAGULATION PEN


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K072911
Device Name ION MEDICAL BIPOLAR COAGULATION PEN
Applicant
ION MEDICAL, LLC
6900 philips highway
suite 41
jacksonville, 
FL 
32216

Applicant Contact keith huron
Correspondent
ION MEDICAL, LLC
6900 philips highway
suite 41
jacksonville, 
FL 
32216

Correspodent Contact keith huron
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 10/12/2007
Decision Date 12/13/2007
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