Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K162747 |
Device Name |
Proture Double Electric Breast Pump |
Applicant |
Guangdong Horigen Mother & Baby Products Co., Ltd. |
NO.8, Yi Road, Pingbei Industrial Zone, Chaoyang District |
Shantou,
CN
515100
|
|
Applicant Contact |
Jun Deng |
Correspondent |
Giangzhou Osmunda Medical Device Technical Service Co., Ltd. |
8-9th Floor, R&D Building, No. 26 Qinglan Street |
Panyu District |
Guangshou,
CN
510006
|
|
Correspondent Contact |
Mike Gu |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 09/30/2016 |
Decision Date | 12/08/2016 |
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
|
|
|