Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K200508 |
Device Name |
Pump In Style |
Applicant |
Medela LLC |
1101 Corporate Drive |
McHenry,
IL
60050
|
|
Applicant Contact |
PJ Pasia |
Correspondent |
Medela LLC |
1101 Corporate Drive |
McHenry,
IL
60050
|
|
Correspondent Contact |
PJ Pasia |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 03/02/2020 |
Decision Date | 06/15/2020 |
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
|
|
|