Device Classification Name |
pump, breast, powered
|
510(k) Number |
K122474 |
Device Name |
LANSINOH POWERED ELECTRIC BREAST PUMP |
Applicant |
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN |
13417 QUIVAS ST |
WESTMINSTER,
CO
80234
|
|
Applicant Contact |
Calley Herzog |
Correspondent |
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN |
13417 QUIVAS ST |
WESTMINSTER,
CO
80234
|
|
Correspondent Contact |
Calley Herzog |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 08/14/2012 |
Decision Date | 12/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|