Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K901344 |
Device Name |
MEDELA BATTERY OPERATED BREAST PUMP |
Applicant |
MEDELA, INC. |
C/O BURDITT & RADZIUS |
333 WEST WACKER DR., STE. 2600 |
CHICAGO,
IL
60606
|
|
Applicant Contact |
JOHN F LEMKER |
Correspondent |
MEDELA, INC. |
C/O BURDITT & RADZIUS |
333 WEST WACKER DR., STE. 2600 |
CHICAGO,
IL
60606
|
|
Correspondent Contact |
JOHN F LEMKER |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 03/22/1990 |
Decision Date | 08/06/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|