Device Classification Name |
Cup, Menstrual
|
510(k) Number |
K121857 |
Device Name |
FEMMYCYCLE |
Applicant |
FEMCAP INCORPORATED |
27001 LA PAZ ROAD, SUITE 312 |
MISSION VIEJO,
CA
92691
|
|
Applicant Contact |
ALBERT REGO |
Correspondent |
FEMCAP INCORPORATED |
27001 LA PAZ ROAD, SUITE 312 |
MISSION VIEJO,
CA
92691
|
|
Correspondent Contact |
ALBERT REGO |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 06/26/2012 |
Decision Date | 11/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|