MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080741
Device Name MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
Applicant
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state st.
draper, 
UT 
84020

Applicant Contact ronda k magneson
Correspondent
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state st.
draper, 
UT 
84020

Correspodent Contact ronda k magneson
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 03/17/2008
Decision Date 12/16/2008
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