| 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
|
|---|