Device Classification Name |
pump, breast, powered
|
510(k) Number |
K143585 |
Device Name |
Electric Breast Pump |
Applicant |
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD |
NO.8, YI ROAD, PINGBEI INDUSTRIAL ZONE |
CHAOYANG DISTRICT |
SHANTOU, GUANGDONG,
CN
515100
|
|
Applicant Contact |
Jun Deng |
Correspondent |
Guangzhou Osmunda Medical Device Technical Services., Ltd. |
7th floor, Jingui Business Building, No. 982 Congyun Rd., |
Baiyun District,
CN
510420
|
|
Correspondent Contact |
Mike Gu |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 12/18/2014 |
Decision Date | 05/06/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|