Device Classification Name |
Pad, Menstrual, Unscented
|
510(k) Number |
K003843 |
Device Name |
ENVIVE MINIFORMS |
Applicant |
PROCTER & GAMBLE CO. |
6110 CENTER HILL AVE. |
CINCINNATI,
OH
45224
|
|
Applicant Contact |
KATHLEEN C BLIEZNER |
Correspondent |
PROCTER & GAMBLE CO. |
6110 CENTER HILL AVE. |
CINCINNATI,
OH
45224
|
|
Correspondent Contact |
KATHLEEN C BLIEZNER |
Regulation Number | 884.5435
|
Classification Product Code |
|
Date Received | 12/12/2000 |
Decision Date | 02/08/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|