Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K082802 |
Device Name |
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B |
Applicant |
LEARNING CURVE BRANDS INC. THE FIRST YEARS |
100 TECHNOLOGY CTR. DR. |
SUITE 2A |
STOUGHTON,
MA
02072
|
|
Applicant Contact |
SUPRAVAN KHONGKRUAPHAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONROY |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 09/24/2008 |
Decision Date | 10/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|