| Device Classification Name |
Pad, Menstrual, Unscented
|
| 510(k) Number |
K940468 |
| Device Name |
FEMININE MAXI PADS |
| Applicant |
| B.A. Wholesale, Inc. |
| 2465 E. Vernon Ave. |
|
Vernon,
CA
90058
|
|
| Applicant Contact |
ROLANDO GOMEZ |
| Correspondent |
| B.A. Wholesale, Inc. |
| 2465 E. Vernon Ave. |
|
Vernon,
CA
90058
|
|
| Correspondent Contact |
ROLANDO GOMEZ |
| Regulation Number | 884.5435 |
| Classification Product Code |
|
| Date Received | 02/02/1994 |
| Decision Date | 05/26/1994 |
| 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
|
|
|