Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K081932 |
Device Name |
ENDEARE BREAST PUMP |
Applicant |
HYGEIA MEDICAL, INC. |
6353 CORTE DEL ABETO |
SUITE 102 |
CARLSBAD,
CA
92011
|
|
Applicant Contact |
JASPER BENKE |
Correspondent |
HYGEIA MEDICAL, INC. |
6353 CORTE DEL ABETO |
SUITE 102 |
CARLSBAD,
CA
92011
|
|
Correspondent Contact |
JASPER BENKE |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 07/07/2008 |
Decision Date | 01/22/2009 |
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
|
|
|