| 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
|
|---|