Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K890588 |
Device Name |
GENTLE EXPRESSIONS ELECTRIC BREAST PUMP |
Applicant |
HEALTHTEAM |
625 MONTROSE AVE. |
SOUTH PLAINFIELD,
NJ
07080
|
|
Applicant Contact |
JOHN CHAMBERS |
Correspondent |
HEALTHTEAM |
625 MONTROSE AVE. |
SOUTH PLAINFIELD,
NJ
07080
|
|
Correspondent Contact |
JOHN CHAMBERS |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 02/06/1989 |
Decision Date | 05/16/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|