| Device Classification Name |
sampler, endocervical
|
|---|
| 510(K) Number |
K122658 |
|---|
| Model |
REFCFCV-013, REF FCV-011, REF FCV-009
|
| Device Name |
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 |
|---|
| Applicant |
| FEMASYS INC. |
| 5000 research court |
| suite 100 |
|
suwanee,
GA
30024
|
|
| Contact |
lisa peacock |
| Regulation Number | 884.1050
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/31/2012 |
|---|
| Decision Date | 12/20/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Obstetrics/Gynecology
|
|---|
| Review Advisory Committee |
Obstetrics/Gynecology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
