Device Classification Name |
cup, menstrual
|
510(k) Number |
K060852 |
Device Name |
MOONCUP |
Applicant |
MOONCUP LIMITED |
DOLPHIN HOUSE |
40 ARUNDEL STREET |
BRIGHTON,
GB
BN2 1GD
|
|
Applicant Contact |
SU HARDY |
Correspondent |
MOONCUP LIMITED |
DOLPHIN HOUSE |
40 ARUNDEL STREET |
BRIGHTON,
GB
BN2 1GD
|
|
Correspondent Contact |
SU HARDY |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 03/28/2006 |
Decision Date | 12/26/2006 |
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
|
|
|