Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K133244 |
Device Name |
TAMPAX M PLASTIC TAMPONS, UNSCENTED |
Applicant |
THE PROCTER & GAMBLE COMPANY |
6110 CENTER HILL AVENUE |
CINCINNATI,
OH
45224
|
|
Applicant Contact |
KATHLEEN BLIESZNER, PH.D. |
Correspondent |
THE PROCTER & GAMBLE COMPANY |
6110 CENTER HILL AVENUE |
CINCINNATI,
OH
45224
|
|
Correspondent Contact |
KATHLEEN BLIESZNER, PH.D. |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 10/22/2013 |
Decision Date | 01/09/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|