Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K102372 |
Device Name |
OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB |
Applicant |
JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO |
BUILDING 1, NO.1, HUIMIN EAST |
RD HUICHENG TOWN, XINHUI DISTR |
JIANGMEN CITY, GUANGDONG,
CN
529100
|
|
Applicant Contact |
CHEN XI |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
WILLIAM J SAMMONS |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/20/2010 |
Decision Date | 11/03/2010 |
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
|