Device Classification Name |
at home intravaginal insemination system
|
510(k) Number |
K231203 |
Device Name |
Mosie Baby Kit |
Applicant |
Mosie Baby |
P.O. Box 140753 |
Austin,
TX
78714
|
|
Applicant Contact |
Maureen Brown |
Correspondent |
Parexel International |
2520 Meridian Parkway, Suite 200 |
Durham,
NC
27713
|
|
Correspondent Contact |
Julie Engel |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 04/27/2023 |
Decision Date | 11/29/2023 |
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
|
|
|