Device Classification Name |
sampler, endocervical
|
510(k) Number |
K122658 |
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
|
|
Applicant Contact |
LISA PEACOCK |
Correspondent |
FEMASYS INC. |
5000 Research Court |
Suite 100 |
Suwanee,
GA
30024
|
|
Correspondent Contact |
LISA PEACOCK |
Regulation Number | 884.1050
|
Classification Product Code |
|
Date Received | 08/31/2012 |
Decision Date | 12/20/2012 |
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
|
|
|