Device Classification Name |
Pump, Breast, Non-Powered
|
510(k) Number |
K013226 |
Device Name |
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT |
Applicant |
EVENFLO COMPANY, INC. |
1000 EVENFLO DR. |
P.O. BOX 709 |
CANTON,
GA
30114
|
|
Applicant Contact |
MATTHEW G MCCARTY |
Correspondent |
EVENFLO COMPANY, INC. |
1000 EVENFLO DR. |
P.O. BOX 709 |
CANTON,
GA
30114
|
|
Correspondent Contact |
MATTHEW G MCCARTY |
Regulation Number | 884.5150
|
Classification Product Code |
|
Date Received | 09/27/2001 |
Decision Date | 12/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|