Device Classification Name |
Kit, Conception-Assist, Home Use
|
510(k) Number |
K140186 |
Device Name |
THE STORK OTC |
Applicant |
RINOVUM WOMEN'S HEALTH, INC |
300 Oxford Dr Suite 330 |
Monroeville,
PA
15146
|
|
Applicant Contact |
ANDREW ZELTWANGER |
Correspondent |
RINOVUM WOMEN'S HEALTH, INC |
300 Oxford Dr Suite 330 |
Monroeville,
PA
15146
|
|
Correspondent Contact |
ANDREW ZELTWANGER |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 01/24/2014 |
Decision Date | 07/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02038322
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|