Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K844936 |
Device Name |
SUPER TAMPAX TAMPONS |
Applicant |
TAMBRANDS, INC. |
2020 K ST. NW |
WASHINGTON,
DC
20006
|
|
Applicant Contact |
JOHN FELLMAN |
Correspondent |
TAMBRANDS, INC. |
2020 K ST. NW |
WASHINGTON,
DC
20006
|
|
Correspondent Contact |
JOHN FELLMAN |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 12/19/1984 |
Decision Date | 02/07/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|