WANDY DISPERSVIE ELECTRODE


Device Classification Name

electrosurgical patient return electrode

510(k) Number K121268
Device Name WANDY DISPERSVIE ELECTRODE
Applicant
BIO-MED USA INC.
111 ellison street
paterson, 
NJ 
07505

Applicant Contact young chi
Correspondent
BIO-MED USA INC.
111 ellison street
paterson, 
NJ 
07505

Correspodent Contact young chi
Regulation Number 878.4400
Classification Product Code
ODR  
Date Received 04/26/2012
Decision Date 12/20/2012
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