Device Classification Name |
pump, breast, powered
|
510(k) Number |
K844307 |
Device Name |
EGNELL-LACT B BATTERY-OPERATED BREAST PUMP |
Applicant |
EGNELL, INC. |
135 SOUTH LA SALLE ST. |
CHICAGO,
IL
60603
|
|
Applicant Contact |
JOHN F LEMKER |
Correspondent |
EGNELL, INC. |
135 SOUTH LA SALLE ST. |
CHICAGO,
IL
60603
|
|
Correspondent Contact |
JOHN F LEMKER |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 10/29/1984 |
Decision Date | 02/04/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|