Device Classification Name |
pump, breast, powered
|
510(k) Number |
K132220 |
Device Name |
PJ'S SERENITY |
Applicant |
LIMERICK, INC. |
2150 N. GLENOAKS BLVD. |
BURBANK,
CA
91504
|
|
Applicant Contact |
PATRICIA KELLY |
Correspondent |
LIMERICK, INC. |
2150 N. GLENOAKS BLVD. |
BURBANK,
CA
91504
|
|
Correspondent Contact |
PATRICIA KELLY |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 07/17/2013 |
Decision Date | 02/20/2015 |
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
|
|
|