Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K203570 |
Device Name |
Mya Joy PLUS Breast Pump |
Applicant |
Ameda, Inc. |
485 Half Day Road; Suite 320 |
Buffalo Grove,
IL
60089
|
|
Applicant Contact |
Carolin Archibald |
Correspondent |
Ameda, Inc. |
485 Half Day Road; Suite 320 |
Buffalo Grove,
IL
60089
|
|
Correspondent Contact |
Sean GM Pettibone |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 12/07/2020 |
Decision Date | 04/22/2021 |
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
|
|
|