Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K170722 |
Device Name |
Moxxly Flow Collection System |
Applicant |
Moxxly, Inc. |
1777 Yosemite Ave. Suite 235 |
San Francisco,
CA
94124
|
|
Applicant Contact |
Cara Delzer |
Correspondent |
Moxxly, Inc. |
1777 Yosemite Ave. Suite 235 |
San Francisco,
CA
94124
|
|
Correspondent Contact |
Rory A. Carrillo |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 03/09/2017 |
Decision Date | 08/28/2017 |
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
|
|
|