MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K021077
Device Name MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
Original Applicant
MEGADYNE MEDICAL PRODUCTS, INC.
11506 south state st.
draper, 
UT 
84020

Original Contact ronda k magneson
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 04/03/2002
Decision Date 04/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No