| Device Classification Name |
Pad, Menstrual, Unscented
|
| 510(k) Number |
K942814 |
| Device Name |
SELF SUPER MAXI SNAITARY NAPKINS |
| Applicant |
| Kegan & Kegan, Ltd. |
| 79 W Monroe St. |
| #1320 |
|
Chicago,
IL
60603 -4969
|
|
| Applicant Contact |
DIANE L PRENDIVILLE |
| Correspondent |
| Kegan & Kegan, Ltd. |
| 79 W Monroe St. |
| #1320 |
|
Chicago,
IL
60603 -4969
|
|
| Correspondent Contact |
DIANE L PRENDIVILLE |
| Regulation Number | 884.5435 |
| Classification Product Code |
|
| Date Received | 06/15/1994 |
| Decision Date | 08/05/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|