Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K210759 |
Device Name |
Solo, Swing Maxi |
Applicant |
Medela LLC |
1101 Corporate Drive |
McHenry,
IL
60050
|
|
Applicant Contact |
Mike McAndrew |
Correspondent |
Medela AG |
Laettichstrasse 4b |
Baar,
CH
6340
|
|
Correspondent Contact |
Jenni Vescovo |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 03/15/2021 |
Decision Date | 08/11/2021 |
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
|
|
|