| Device Classification Name |
Pad, Menstrual, Unscented
|
| 510(k) Number |
K933950 |
| Device Name |
LADY'S CARE MAXI PADS |
| Applicant |
| LADY'S CARE, INC. |
| 362 2ND ST. PIKE |
| SUITE 146 |
|
SOUTHAMPTON,
PA
18966
|
|
| Applicant Contact |
LEE BORDEAUX |
| Correspondent |
| LADY'S CARE, INC. |
| 362 2ND ST. PIKE |
| SUITE 146 |
|
SOUTHAMPTON,
PA
18966
|
|
| Correspondent Contact |
LEE BORDEAUX |
| Regulation Number | 884.5435 |
| Classification Product Code |
|
| Date Received | 08/12/1993 |
| Decision Date | 04/13/1994 |
| 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
|
|
|