Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K130027 |
Device Name |
DISPOSABLE NEUTRAL ELECTRODE GP202 |
Applicant |
CATHAY MANUFACTURING CORP. |
NO. 328, XISHE ROAD, MAOGANG TOWN, SONGJIANG AREA |
SHANGHAI,
CN
201607
|
|
Applicant Contact |
ZHANG HUI |
Correspondent |
CATHAY MANUFACTURING CORP. |
NO. 328, XISHE ROAD, MAOGANG TOWN, SONGJIANG AREA |
SHANGHAI,
CN
201607
|
|
Correspondent Contact |
ZHANG HUI |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/03/2013 |
Decision Date | 08/22/2013 |
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
|
|
|