Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K190465 |
Device Name |
Evolve Breast Pump |
Applicant |
Hygeia II Medical Group, Inc. |
6241 Yarrow Drive |
Carlsbad,
CA
92011
|
|
Applicant Contact |
Brett Nakfoor |
Correspondent |
Hygeia II Medical Group, Inc. |
6241 Yarrow Drive |
Carlsbad,
CA
92011
|
|
Correspondent Contact |
Brett Nakfoor |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 02/26/2019 |
Decision Date | 10/18/2019 |
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
|
|
|