| Device Classification Name |
Pad, Menstrual, Scented, Scented-Deodorized
|
| 510(k) Number |
K884951 |
| Device Name |
TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT |
| Applicant |
| Tambrands, Inc. |
| Bridge & Springfield St.s |
|
Palmer,
MA
01069
|
|
| Applicant Contact |
DAVIS, PHD |
| Correspondent |
| Tambrands, Inc. |
| Bridge & Springfield St.s |
|
Palmer,
MA
01069
|
|
| Correspondent Contact |
DAVIS, PHD |
| Regulation Number | 884.5425 |
| Classification Product Code |
|
| Date Received | 11/25/1988 |
| Decision Date | 01/10/1989 |
| 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
|
|
|