Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K200712 |
Device Name |
Rumble Tuff Electric Breast Pump |
Applicant |
A Cute Baby, Inc. |
865 N 1430 W |
Orem,
UT
84057
|
|
Applicant Contact |
Matthew Kho |
Correspondent |
A Cute Baby, Inc. |
865 N 1430 W |
Orem,
UT
84057
|
|
Correspondent Contact |
Matthew Kho |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 03/18/2020 |
Decision Date | 04/17/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|