Device Classification Name |
pump, breast, powered
|
510(k) Number |
K191802 |
Device Name |
Electric Breast Pump |
Applicant |
Ningbo Huiyoo Baby Products Co. Ltd. |
523# Cizhang Road, Zhangqi Industrial Area |
Cixi,
CN
315313
|
|
Applicant Contact |
Xiaoping Liu |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 07/03/2019 |
Decision Date | 01/16/2020 |
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
|
|
|