Device Classification Name |
pump, breast, powered
|
510(k) Number |
K172842 |
Device Name |
GCE704 Breast Pump |
Applicant |
Globalcare |
No7 factory European Ind. Park |
No. 39 mid Industrial main Rd |
Xiaolan Town, Zhongshan City,
CN
528415
|
|
Applicant Contact |
Chiara Cavagnolo |
Correspondent |
Project mMrketing |
112 Caviston Way |
Cary,
NC
27519
|
|
Correspondent Contact |
Terrence M. O'Brien |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 09/19/2017 |
Decision Date | 06/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|