Device Classification Name |
Cup, Menstrual
|
510(k) Number |
K021356 |
Device Name |
THE DIVACUP MENSTRUAL SOLUTION |
Applicant |
DIVA INTERNATIONAL INC |
P.O. BOX 25089 |
1375 WEBER STREET E |
KITCHENER ONTARIO,
CA
N2A 4A5
|
|
Applicant Contact |
FRANCINE CHAMBERS |
Correspondent |
DIVA INTERNATIONAL INC |
P.O. BOX 25089 |
1375 WEBER STREET E |
KITCHENER ONTARIO,
CA
N2A 4A5
|
|
Correspondent Contact |
FRANCINE CHAMBERS |
Regulation Number | 884.5400
|
Classification Product Code |
|
Date Received | 04/29/2002 |
Decision Date | 07/16/2002 |
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
|