Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K061013 |
Device Name |
PLAYTEX EMBRACE PETITE BREAST PUMP |
Applicant |
PLAYTEX PRODUCTS, INC. |
75 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Applicant Contact |
KARIN E JORDAN |
Correspondent |
PLAYTEX PRODUCTS, INC. |
75 COMMERCE DR. |
ALLENDALE,
NJ
07401 -1600
|
|
Correspondent Contact |
KARIN E JORDAN |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 04/13/2006 |
Decision Date | 08/15/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|