Device Classification Name |
Pump, Breast, Non-Powered
|
510(k) Number |
K823840 |
Device Name |
MEDELA NAMUAL BREAST PUMP |
Applicant |
MEDELA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDELA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.5150
|
Classification Product Code |
|
Date Received | 12/21/1982 |
Decision Date | 01/24/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|