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
|
|
Correspondent Contact |
YOUNG CHI |
Regulation Number | 878.4400
|
Classification Product Code |
|
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
|