Device Classification Name |
Cannula, Manipulator/Injector, Uterine
|
510(k) Number |
K110288 |
Device Name |
FEMVUE SALINE-AIR DEVICE |
Applicant |
FEMASYS INC. |
5000 RESEARCH COURT STE .100 |
SUWANEE,
GA
30024
|
|
Applicant Contact |
LISA PEACOCK |
Correspondent |
FEMASYS INC. |
5000 RESEARCH COURT STE .100 |
SUWANEE,
GA
30024
|
|
Correspondent Contact |
LISA PEACOCK |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 02/01/2011 |
Decision Date | 04/28/2011 |
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
|
|
|