Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K141742 |
Device Name |
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS |
Applicant |
ARDO MEDICAL AG |
1835 MARKET STREET, 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
YARMELA PAVLOVIC |
Correspondent |
ARDO MEDICAL AG |
1835 MARKET STREET, 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
YARMELA PAVLOVIC |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 06/27/2014 |
Decision Date | 10/17/2014 |
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
|
|
|