Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K033131 |
Device Name |
NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 |
Applicant |
THE FIRST YEARS, INC. |
ONE KIDDIE DR. |
AVON,
MA
02322
|
|
Applicant Contact |
ROBIN C CONNER |
Correspondent |
THE FIRST YEARS, INC. |
ONE KIDDIE DR. |
AVON,
MA
02322
|
|
Correspondent Contact |
ROBIN C CONNER |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 09/30/2003 |
Decision Date | 10/30/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|